Related Impurities

Cephalexin or Cefalexin is an antibiotic used to treat various infections. It kills gram-positive and some gram-negative bacteria by disrupting the growth of the bacterial cell wall. Cefalexin is a beta-lactam antibiotic within the class of first-generation cephalosporins. It works similarly to other agents within this class. Cephalexin is a hydrophobic zwitterionic compound and its impurities can be hydrophilic, hydrophobic, basic, acidic, and zwitterionic. Coresep 100 columns retain and separate these compounds without the use of ion-pairing reagents. Various buffers at different pH can be used to control the ionization state of the analytes and stationary phase. Coresep 100 columns can be used to analyze drugs and related impurities and provide perfect peak shape and retention control. The columns are suitable for robust method development and validation.

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Conditions of Experiment

Column:	Coresep 100
Separation Modes:	reversed-phase, cation-exchange
Column Dimenstions:	4.6x150 mm, 2.7 um, 90A
Mobile Phase:	A: 10% ACN with 10 mM NaH2PO4 pH 3.1 B: 40% ACN with 40 mM NaH2PO4 pH 3.1 from 100% A to 100% B in 8 min, 5 min hold
Detection:	UV 275
Sample:	various
Injection:	3 uL
Flow rate:	1 ml/min

Analytes

Class of compounds:	Antibiotic, Aromatic acid, Aromatic base, Drug
Nature of compounds:	Basic, Hydrophilic, Hydrophobic
Compounds:	Cefadroxil, Related Impurities

Cefadroxil is a broad-spectrum antibiotic effective in the treatment of Gram-positive and Gram-negative infections. It is an organic zwitterionic compound with medium hydrophobicity. We have developed a method for analysis of this antibiotic on Coresep 100 core-shell reversed-phase cation-exchange column. It retains compounds based on RP and cation-exchange mechanisms. Retention of the antibiotic and related impurities can be effectively controlled by the amount of ACN, buffer concentration, and buffer pH. The choice of the buffer depends on the sample matrix and detection technique. Column and method are compatible with common detection techniques like UV, ELSD, CAD, MS, and RI. The method is robust and reproducible and can be used to analyze complex mixtures either in a single or dual mode. Mixed-mode HPLC columns from HElIX offer robust and reliable separation. Peak shapes are symmetrical and demonstrate high efficiency attributed to core-shell particles. Mixed-mode HPLC columns are a good choice for method development and validation for various drugs, drug composition, and remedies.

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Conditions of Experiment

Column:	Coresep 100
Separation Modes:	reversed-phase, cation-exchange
Column Dimenstions:	4.6x150 mm, 2.7 um, 90A
Mobile Phase:	A: 10% ACN with 10 mM NaH2PO4 pH 3.1 B: 40% ACN with 40 mM NaH2PO4 pH 3.1 from 100% A to 100% B in 8 min, 5 min hold
Detection:	UV 255
Sample:	2 mg/ml
Injection:	3 uL
Flow rate:	1 ml/min

Analytes

Class of compounds:	Antibiotic, Aromatic acid, Aromatic base, Drug
Nature of compounds:	Basic, Hydrophilic, Hydrophobic
Compounds:	Cefadroxil, Related Impurities

Guaifenesin is medication which is used to help with clearing airways from phlegm and mucus. It is a relatively hydrophobic and neutral compound. We have developed a method for analysis of guaifenesin and related impurities in various drug formulations. The compound is retained on a Coresep 100 column by a pure reversed-phase mechanism. Retention time is controlled by the amount of acetonitrile in the mobile phase. Buffer selection depends on the detection technique used to monitor guaifenesin and related impurities. Coresep 100 HPLC column is a reversed-phase cation-exchange column, based on core-shell particles. It demonstrates very high efficiency and robustness as well as a unique alternative to RP and HILIC selectivity.

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Conditions of Experiment

Column:	Coresep 100
Separation Modes:	reversed-phase, cation-exchange
Column Dimenstions:	4.6x150 mm, 2.7 um, 90A
Mobile Phase:	A: 15% ACN with 0.02% H2SO4 B: 50% ACN with 0.2% H2SO4 from 100% A to 100% B in 8 min, 4 min hold
Detection:	UV 255
Sample:	2 mg/ml
Injection:	3 uL
Flow rate:	1 ml/min

Analytes

Class of compounds:	Aromatic acid, Aromatic base, Aromatic compound, Drug
Nature of compounds:	Basic, Hydrophilic, Hydrophobic, Neutral, Polar
Compounds:	Guaifenesin, Related Impurities

Morphine is used to relieve moderate to severe pain. It belongs to the group of medicines called narcotic analgesics (pain medicines). Morphine acts on the central nervous system (CNS) to relieve pain. When morphine is used for a long time it can cause addiction. Morphine and related impurities were analyzed by mixed-mode chromatography on Coresep core-shell multi-mode column. Retention time is controlled by amount of ACN, buffer concentration and buffer pH. This method can be used in bioanalysis to quantify morphine in biofluids and drug formulations. Core-shell mixed-mode columns offer combination of unique selectivity and high efficiency while using regular equipment.

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Conditions of Experiment

Column:	Coresep 100
Separation Modes:	reversed-phase and cation-exchange
Column Dimenstions:	3.0 x 100 mm
Mobile Phase:	45% ACN with 20 mM AmFm pH 3
Detection:	UV 275 nm
Sample:	0.3 mg/ml
Injection:	1 uL
Flow rate:	0.8 mL/min

Analytes

Class of compounds:	Aromatic acid, Aromatic base, Controlled substance, Drug
Nature of compounds:	Basic, Hydrophilic, Hydrophobic
Compounds:	Morphine, Related Impurities

Cocaine is a powerful and highly addictive stimulant. Cocaine is a Schedule II controlled substance. Cocaine is the second most frequently used drug. It is hydrophobic and basic in nature. We have analyzed cocaine and related impurity on core-shell Coresep 100 mixed-mode column in reversed-phase cation-exchange modes. Core-shell mixed-mode chromatography offers a synergy of unique selectivity of mixed-mode stationary phases and high efficiency of core-shell particles. The method can be used for analysis of cocaine and other illegal drugs in various sample matrices. This method is compatible with major detection techniques including mass spectrometry.

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Conditions of Experiment

Column:	Coresep 100
Separation Modes:	reversed-phase and cation-exchange
Column Dimenstions:	3.0 x 100 mm
Mobile Phase:	60% ACN with 30 mM AmFm pH 3
Detection:	UV 275 nm
Sample:	0.3 mg/ml
Injection:	1 uL
Flow rate:	0.8 mL/min

Analytes

Class of compounds:	Aromatic acid, Aromatic base, Controlled substance, Drug, Illegal drug
Nature of compounds:	Basic, Hydrophilic, Hydrophobic
Compounds:	Cocaine, Related Impurities

Diclobutrazol is a racemic mixture of two chemical compounds from the triazole group, which acts as a fungicide. Itis normally applied to the soil to be taken up by the roots and transported via the xylem to the upper parts of the plant. Seeds can be soaked with diclobutrazol to reduce seedling growth. Diclobutrazol is hydrophobic and slightly basic. It is retained on Coresep 100 column by combining a strong reversed-phase mechanism with a weak cation-exchange mechanism. Retention time is controlled by amount of ACN and to a lesser degree by buffer concentration and buffer pH. Method is fast, robust, reproducible, and can be used for analysis of diclobutrazol in various matrices (crops, soil, waste water, etc.). Various mobile phases can be used with Coresep 100 column to accommodate different detection techniques (UV, MS, CAD, ELSD detection). Core-shell mixed-mode columns provide a great combination of unique selectivity, speed, and efficiency.

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Conditions of Experiment

Column:	Coresep 100
Separation Modes:	reversed-phase and anion-exchange
Column Dimenstions:	3.2 x 100 mm
Mobile Phase:	40% ACN with 50 mM AmFm pH 3
Detection:	UV 275 nm
Sample:	0.3 mg/ml
Injection:	1 uL
Flow rate:	0.6 mL/min

Analytes

Class of compounds:	Aromatic acid, Aromatic base, Drug, Fungicide, Herbicide
Nature of compounds:	Basic, Hydrophilic, Hydrophobic, Neutral
Compounds:	Diclobutrazol, Related Impurities

Fluoxetine (Prozac) is an antidepressant of the selective serotonin reuptake inhibitor(SSRI) class. It is used for the treatment of major depressive disorder, obsessive-compulsive disorder (OCD), bulimia nervosa, panic disorder and premenstrual dysphoric disorder. Fluoxetine is hydrophobic and basic in nature. Fluoxetine and related impurities were analyzed by mixed-mode chromatography on Heritage MA HPLC column. Compounds are separated by reversed-phase and cation-exclusion mechanisms. Retention time, selectivity, and resolution between peaks can be adjusted by modification of amount of ACN, buffer and buffer pH. Various mobile phases can be used with Heritage MA column to accommodate different detection techniques (UV, MS, CAD, ELSD detection).

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Conditions of Experiment

Column:	Heritage MA
Separation Modes:	reversed-phase and cation-exclusion
Column Dimenstions:	4.6 x 150 mm
Mobile Phase:	15% ACN with 0.2% H3PO4
Detection:	UV 215 nm
Sample:	0.3 mg/ml
Injection:	3 uL
Flow rate:	1 mL/min

Analytes

Class of compounds:	Aromatic acid, Aromatic base, Drug
Nature of compounds:	Basic, Hydrophilic, Hydrophobic
Compounds:	Prozac (fluoxetine), Related Impurities

Montelukast is a leukotriene receptor antagonist (LTRA) used for the maintenance treatment of asthma and to relieve symptoms of seasonal allergies. It is effectively used to treat asthma attacks. Montelukast is hydrophobic and zwitterionic in nature. It contains carboxylic acid and quinoline fragments. Montelukast and related impurities were analyzed and separated by mixed-mode chromatography using the Heritage MA mixed-mode column. Montelukast is retained and separated from other impurities by strong hydrophobic and strong cation-exclusion interactions. Retention time, selectivity, and resolution between peaks can be adjusted by modification of amount of ACN, buffer and buffer pH. Various mobile phases can be used with Heritage MA column to accommodate different detection techniques (UV, MS, CAD, ELSD detection).

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Conditions of Experiment

Column:	Heritage MA
Separation Modes:	reversed-phase and cation-exchange
Column Dimenstions:	4.6 x 150 mm
Mobile Phase:	50% ACN with 0.2% H3PO4
Detection:	UV 215 nm
Sample:	0.3 mg/ml
Injection:	3 uL
Flow rate:	1 mL/min

Analytes

Class of compounds:	Aromatic acid, Aromatic base, Drug
Nature of compounds:	Basic, Hydrophilic, Hydrophobic, Zwitterionic
Compounds:	Montelukast, Related Impurities

Cefuroxime is the second generation cephalosporin antibiotic. It is hydrophobic and acidic in nature. Cefuroxime and related impurities were analyzed by mixed-mode HPLC on Coresep 100 column. Retention time is controlled by the amount of ACN, buffer concentration, and buffer pH. The method is fast, robust, reproducible, and can be used for analysis of cefuroxime in various samples. Various mobile phases can be used with Coresep 100 column to accommodate different detection techniques (UV, MS, CAD, ELSD detection). Core-shell mixed-mode columns provide a great combination of unique selectivity, speed, and efficiency.

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Conditions of Experiment

Column:	Coresep 100
Separation Modes:	reversed-phase and anion-exclusion
Column Dimenstions:	3.0 x 100 mm
Mobile Phase:	35% ACN with 0.1% H3PO4
Detection:	UV 255 nm
Sample:	0.3 mg/ml
Injection:	3 uL
Flow rate:	1 mL/min

Analytes

Class of compounds:	Antibiotic, Aromatic acid, Aromatic base, Drug
Nature of compounds:	Basic, Hydrophilic, Hydrophobic, Polar, Zwitterionic
Compounds:	Cefuroxime (two isomers), Related Impurities

Fluconazole is an antifungal drug. It is a highly selective inhibitor of fungal cytochrome P-450 sterol C-14 α-demethyllation. Fluconazole is a potent inhibitor of CYP2C9. Fluconazole interferes with fungal ergosterol synthesis and downregulates the metallothionein gene. Fluconazole is a first-generation triazole antifungal medication. It differs from earlier azole antifungals (such as ketoconazole) because its structure contains a triazole ring instead of an imidazole ring. Fluconazole and related impurities were analyzed by mixed-mode chromatography on Coresep 100 HPLC column. Fluconazole is hydrophobic and slightly basic in nature. It is retained on Coresep 100 column by combining strong reversed-phase and weak cation-exchange mechanisms. The amount of oACN in mobile phase affects retention of this compound the most. Buffer concentration, buffer pH, and buffer nature can be used for fine tuning for the separation of fluconazole and related impurities. Various mobile phases can be used with Coresep 100 column to accommodate different detection techniques (UV, MS, CAD, ELSD detection). Core-shell mixed-mode columns provide a great combination of unique selectivity, speed, and efficiency.

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Conditions of Experiment

Column:	Coresep 100
Separation Modes:	reversed-phase and cation-exchange
Column Dimenstions:	4.6 x 150 mm
Mobile Phase:	35% ACN with 0.1% H3PO4
Detection:	UV 235 nm
Sample:	0.3 mg/ml
Injection:	3 uL
Flow rate:	1 mL/min

Analytes

Class of compounds:	Aromatic acid, Aromatic base, Drug
Nature of compounds:	Basic, Hydrophilic, Hydrophobic
Compounds:	Fluconazole, Related Impurities

Amphetamine is a stimulant of the phenethylamine class found in ADHD-treatment drugs such as Adderall®, Vyvanse®, and ProCentra®. Because of its stimulant effect, amphetamine is used recreationally as a performance-enhancer and an illicit drug. It is a potent stimulant and a Schedule II drug. Amphetamine properly refers to a specific chemical, the racemic free base, which is equal parts of the two enantiomers, levoamphetamine and dextroamphetamine, in their pure amine forms. It is slightly hydrophobic and basic in nature. Amphetamine and related impurities were analyzed without the use of ion-pairing reagent on Coresep 100 mixed-mode HPLC column. Amphetamine is retained by weak reversed-phase mechanism and by strong cation-exchange mechanism. Method is fast, robust, reproducible, and can be used for analysis of amphetamine and other hydrophilic basic drugs by mixed-mode chromatography in various samples. Various mobile phases can be used with Coresep 100 column to accommodate different detection techniques (UV, MS, CAD, ELSD detection). Core-shell mixed-mode columns provide great combination of unique selectivity, speed, and efficiency.

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Conditions of Experiment

Column:	Coresep 100
Separation Modes:	reversed-phase and cation-exchange
Column Dimenstions:	3.0 x 100 mm
Mobile Phase:	30% ACN with 0.1% TFA
Detection:	UV 215 nm
Sample:	0.3 mg/ml
Injection:	1 uL
Flow rate:	0.5 mL/min

Analytes

Class of compounds:	Aromatic acid, Aromatic base, Drug, Stimulant
Nature of compounds:	Basic, Hydrophilic, Hydrophobic
Compounds:	Amphetamine, Related Impurities

Metoclopramide is a drug used for treatment of stomach and esophageal problems. It is commonly used to treat and prevent nausea and vomiting. It is also used to treat migraine headaches. It is also used to treat the symptoms of gastroparesis. Metoclopramide is hydrophobic and basic in nature. It has two ionizable basic groups - aniline fragment and secondary amine. The drug and related impurities were separated on Coresep 100 HPLC column by combining reversed-phase and cation-exchange mechanisms. The method can be used for analysis of hydrophobic basic compounds in reversed-phase cation-exchange mode. Retention time is controlled by the amount of ACN, buffer concentration and buffer pH. The method is fast, robust, reproducible, and can be used for analysis of metoclopramide in various samples. Various mobile phases can be used with Coresep 100 column to accommodate different detection techniques (UV, MS, CAD, ELSD detection). Core-shell mixed-mode columns provide a great combination of unique selectivity, speed, and efficiency.

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Conditions of Experiment

Column:	Coresep 100
Separation Modes:	reversed-phase and cation-exchange
Column Dimenstions:	4.6 x 150 mm
Mobile Phase:	65% ACN with 0.2% H3PO4
Detection:	UV 235 nm
Sample:	0.3 mg/ml
Injection:	3 uL
Flow rate:	1 mL/min

Analytes

Class of compounds:	Aromatic acid, Aromatic base, Drug
Nature of compounds:	Basic, Hydrophilic, Hydrophobic
Compounds:	Metoclopramide, Related Impurities

Ondansetron is a drug used for treatment of nausea and vomiting caused by cancer chemotherapy and radiation therapy. Ondansetron is a serotonin 5-HT3 receptor antagonist. The drug is hydrophobic and slightly basic. Ondansetron and related impurities were separated on Coresep 100 column by combination of reversed-phase and cation-exchange mechanisms. The method is robust, reproducible, and can be used for analysis of ondansetron in formulation, biofluids, and other matrices. Various mobile phases can be used with Coresep 100 column to accommodate different detection techniques (UV, MS, CAD, ELSD detection). Core-shell mixed-mode columns provide a great combination of unique selectivity, speed, and efficiency.

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Conditions of Experiment

Column:	Coresep 100
Separation Modes:	reversed-phase and cation-exchange
Column Dimenstions:	4.6 x 150 mm
Mobile Phase:	65% ACN with 0.2% H3PO4
Detection:	UV 255 nm
Sample:	0.3 mg/ml
Injection:	3 uL
Flow rate:	1 mL/min

Analytes

Class of compounds:	Aromatic acid, Aromatic base, Drug
Nature of compounds:	Basic, Hydrophilic, Hydrophobic
Compounds:	Ondansetron, Related Impurities

Phentermine is a drug with pharmacology similar to amphetamines. Phentermine is a sympathomimetic that releases norepinephrine and epinephrine in CNS and periphery reducing hunger. Similarly to other amphetamines, phentermine potently inhibits DA and 5-HT uptake. It is a psychostimulant drug which has Schedule IV classification in US. It is slightly hydrophobic in nature and has basic properties due to the presence of primary amine. HPLC analysis of phentermine and related impurities was performed on Coresep 100 mixed-mode column. Method is robust with good peak shape for main compound. Method can be used for analysis of hydrophobic basic compounds in reversed-phase cation-exchange mode. Retention time is controlled by the amount of ACN, buffer concentration and buffer pH. Method is robust and reproducible and can be used for analysis of phentermine in formulation, biofluids, and other compositions. Various mobile phases can be used with Coresep 100 column to accommodate different detection techniques (UV, MS, CAD, ELSD detection). Core-shell mixed-mode columns provide great combination of unique selectivity, speed, and efficiency.

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Conditions of Experiment

Column:	Coresep 100
Separation Modes:	reversed-phase and cation-exchange
Column Dimenstions:	3.0 x 100 mm
Mobile Phase:	30% ACN with 0.1% TFA
Detection:	UV 255 nm
Sample:	0.3 mg/ml
Injection:	1 uL
Flow rate:	0.5 mL/min

Analytes

Class of compounds:	Aromatic acid, Aromatic base, Controlled substance, Drug, Stimulant
Nature of compounds:	Basic, Hydrophilic, Hydrophobic
Compounds:	Phentermine, Related Impurities

Bupropion is a medication primarily used as an antidepressant and smoking cessation aid. It is an effective antidepressant on its own, but is also used as an add-on medication in cases of incomplete response to first-line SSRI antidepressants.Common side effects include dry mouth, trouble sleeping, agitation, and headaches. It is a norepinephrine-dopamine reuptake inhibitor (NDRI) and a nicotinic receptor antagonist. It is an atypical antidepressant, different from most others. Bupropion is classified as cathinones and is similar in structure to substituted phenethylamines. Bupropion and related impurities were separated by mixed-mode chromatography without the use of ion-pairing reagents (IP reagent). Compounds are retained on Coresep 100 column by combination of reversed-phase and cation-exchange mechanisms. Retention time, selectivity, and resolution between peaks can be adjusted by modification of amount of ACN, buffer, and buffer pH. Various mobile phases can be used with Coresep 100 column to accommodate various detection techniques (UV, MS, CAD, ELSD detection). Core-shell mixed-mode columns provide a great combination of unique selectivity, speed, and efficiency.

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Conditions of Experiment

Column:	Coresep 100
Separation Modes:	reversed-phase and cation-exchange
Column Dimenstions:	3.0 x 100 mm
Mobile Phase:	30% ACN with 0.1% TFA
Detection:	UV 255 nm
Sample:	0.3 mg/ml
Injection:	1 uL
Flow rate:	0.5 mL/min

Analytes

Class of compounds:	Aromatic acid, Aromatic base, Drug
Nature of compounds:	Basic, Hydrophilic, Hydrophobic
Compounds:	Bupropion, Related Impurities

Torbutrol is a morphine type synthetic opioid analgesic. Torbutrol is used in migraine pain management. Compound is hydrophobic and basic in nature. Torbutrol was analyzed on Coresep 100 mixed-mode core-shell column in RP/cation-exchange mode. Retention time is controlled by amount of ACN, buffer concentration and buffer pH. Method is fast, robust, reproducible, and can be used for analysis of torbutrol in various sample matrices. Various mobile phases can be used with Coresep 100 column to accommodate different detection techniques (UV, MS, CAD, ELSD detection). Core-shell mixed-mode columns provide a great combination of unique selectivity, speed, and efficiency.

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Conditions of Experiment

Column:	Coresep 100
Separation Modes:	reversed-phase and cation-exchange
Column Dimenstions:	3.0 x 100 mm
Mobile Phase:	65% ACN with 0.1% of H3PO4
Detection:	UV 215 nm
Sample:	0.3 mg/ml
Injection:	1 uL
Flow rate:	0.6 mL/min

Analytes

Class of compounds:	Aromatic acid, Aromatic base, Controlled substance, Drug
Nature of compounds:	Basic, Hydrophilic, Hydrophobic
Compounds:	Torbutrol, Related Impurities

Loratadine is a drug which is used to treat allergies. It is available in combination with pseudoephedrine in different forms including tablets, oral suspensions, and syrop. Loratadine and related impurities were separated on Heritage MC mixed-mode column by combination of reversed-phase and cation-exchange mechanisms. Retention time is controlled by amount of ACN, buffer concentration, and buffer pH. Method is fast, robust, reproducible, and can be used for analysis of loratadine in various samples. Various mobile phases can be used with Heritage MC column to accommodate different detection techniques. UV transparent buffers can be replaced with volatile buffers for MS, ELSD or CAD detection.

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Conditions of Experiment

Column:	Heritage MC
Separation Modes:	reversed-phase and cation-exchange
Column Dimenstions:	4.6 x 150 mm
Mobile Phase:	60% ACN with 60 mM AmAc pH 5
Detection:	UV 255 nm
Sample:	0.3 mg/ml
Injection:	3 uL
Flow rate:	1 mL/min

Analytes

Class of compounds:	Aromatic acid, Aromatic base, Drug, Pyridine
Nature of compounds:	Basic, Hydrophilic, Hydrophobic
Compounds:	Loratadine, Related Impurities

Meclizine is a histamine H1 receptor antagonist which is used as a drug to treat nausea. It also serves as inhibitor of hepstin. It is used to treat motion sickness. Meclizine is a first generation antihistamine of piperazine class. It is hydrophobic and basic in nature. Poor peak shape is observed on traditional reversed-phase columns due to interaction of basic groups with residual silanols. This problem of poor peak shape was addressed by using Coresep SB mixed-mode column. Basic group on the surface of Coresep SB provides a shielding effect, and silanols do not interact with basic sites of the molecule. The compound retains on Coresep SB column by combination of reversed-phase and cation-exclusion mechanisms. Retention time is controlled by amount of ACN, buffer concentration, and buffer pH. Method is fast, robust, reproducible, and can be used for analysis of meclizine in various matrices (reaction mixtures, formulations, biofluids). Various mobile phases can be used with Coresep SB column to accommodate different detection techniques. UV transparent buffers can be replaced with volatile buffers for MS, ELSD or CAD detection. Core-shell mixed-mode columns provide a great combination of unique selectivity, speed, and efficiency.

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Conditions of Experiment

Column:	Coresep SB
Separation Modes:	reversed-phase and cation-exclusion
Column Dimenstions:	3.0 x 100 mm
Mobile Phase:	20% ACN with 0.2% of H3PO4
Detection:	UV 215 nm
Sample:	0.3 mg/ml
Injection:	1 uL
Flow rate:	0.6 mL/min

Analytes

Class of compounds:	Aromatic acid, Aromatic base, Drug
Nature of compounds:	Basic, Hydrophilic, Hydrophobic
Compounds:	Meclizine, Related Impurities

Ciprofloxacin is an antibiotic drug used to treat bacterial infections. It does not treat viral infections like common cold. Ciprofloxacin is the most widely used of the second-generation quinolones. The molecule is hydrophobic and zwitterionic in nature. Carboxylic acid ionization on the molecule can be suppressed by using low pH mobile phase (below 3). Ciprofloxacin and related impurities were separated on Coresep SB mixed-mode column in reversed-phase cation-exclusion modes. Method is fast, robust, reproducible, and can be used for analysis of ciprofloxacin in various matrices (reaction mixtures, formulations, biofluids). Various mobile phases can be used with Coresep SB column to accommodate different detection techniques. UV transparent buffers can be replaced with volatile buffers for MS, ELSD or CAD detection. Core-shell mixed-mode columns provide a great combination of unique selectivity, speed, and efficiency.

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Conditions of Experiment

Column:	Coresep SB
Separation Modes:	reversed-phase and cation-exchange
Column Dimenstions:	3.0 x 100 mm
Mobile Phase:	5% ACN with 0.2% of H3PO4
Detection:	UV 215 nm
Sample:	0.3 mg/ml
Injection:	1 uL
Flow rate:	0.6 mL/min

Analytes

Class of compounds:	Antibiotic, Aromatic acid, Aromatic base, Drug
Nature of compounds:	Basic, Hydrophilic, Hydrophobic, Polar, Zwitterionic
Compounds:	Ciprofloxacin, Related Impurities

Synthroid (Levothyroxine) is a drug used to treat thyroid hormone deficiency. Levothyroxine is hydrophobic and zwitterionic molecule. The compound retains on Coresep SB column by combination of reversed-phase and cation-exclusion mechanisms. Retention time is controlled by amount of ACN, buffer concentration, and buffer pH. Method is fast, robust, reproducible, and can be used for analysis of synthroid in various matrices (reaction mixtures, formulations, biofluids). Various mobile phases can be used with Coresep SB column to accommodate different detection techniques. UV transparent buffers can be replaced with volatile buffers for MS, ELSD or CAD detection. Core-shell mixed-mode columns provide a great combination of unique selectivity, speed, and efficiency.

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Conditions of Experiment

Column:	Coresep SB
Separation Modes:	reversed-phase, cation-exclusion and anion-exchange
Column Dimenstions:	3.0 x 100 mm
Mobile Phase:	30% ACN with 0.2% of H3PO4
Detection:	UV 215 nm
Sample:	0.3 mg/ml
Injection:	1 uL
Flow rate:	0.6 mL/min

Analytes

Class of compounds:	Aromatic acid, Aromatic base, Aromatic compound, Drug
Nature of compounds:	Basic, Hydrophilic, Hydrophobic, Zwitterionic
Compounds:	Synthroid (Levothyroxine), Related Impurities

Cetirizine is an antihistamine drug used for the treatment of fevers, allergies, angioedema, and urticaria. It acts as a selective antagonist of the histamine H1 receptor. It is a non-sedating, histamine H1-receptor antagonist and major metabolite of Hydroxyzine. It is a hydrophobic and zwitterionic compound. The HPLC analysis of Cetirizine on the Coresep SB column is robust and reproducible with a perfect peak shape for the main analyte. The residual silanols are shielded by a positively charged group on the surface of silica gel. Cetirizine and related impurities were separated based on hydrophobic and ionic properties of API and impurities. This method can be used for the analysis of hydrophobic basic compounds in reversed-phase cation-exclusion mode. Various mobile phases can be used with Coresep SB column to accommodate differing detection techniques (UV, MS, CAD, ELSD detection). The Coresep SB is a perfect choice for the analysis of hydrophobic basic compounds as well as neutral and polar acidic compounds. The retention time is controlled by a mobile phase composition. The amount of ACN, buffer pH and buffer concentration will affect the elution and separation between compounds. Core-shell mixed-mode columns provide great combination of unique selectivity, speed and efficiency.

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Conditions of Experiment

Column:	Coresep SB
Separation Modes:	reversed-phase and anion-exchange
Column Dimenstions:	3.0 x 100 mm
Mobile Phase:	15% ACN with 0.2% of H3PO4
Detection:	UV 215 nm
Sample:	0.3 mg/ml
Injection:	1 uL
Flow rate:	0.6 mL/min

Analytes

Class of compounds:	Aromatic acid, Aromatic base, Drug
Nature of compounds:	Basic, Hydrophilic, Hydrophobic
Compounds:	Cetirizine, Related Impurities

Loratadine is a non-sedating anti-allergy medication. It is available as a single component drug formulation or a composition with decongestant pseudoephedrine. Loratadine is a hydrophobic and slightly basic compound with a pKa around 5. Loratadine and related impurities were analyzed on the Coresep SB mixed-mode column. Compounds are retained based on reversed-phase and cation-exclusion mechanisms. The method is fast, robust and reproducible, not requiring ion-pairing reagents (IPC). Numerous mobile phases can be used with Coresep 100 column to accommodate various detection techniques. UV transparent buffers can be replaced with volatile buffers for MS, ELSD or CAD detection. The approach can be used for quantification of loratadine and related impurities in multiple matrices. Core-shell mixed-mode columns provide great combination of unique selectivity, speed and efficiency.

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Conditions of Experiment

Column:	Coresep SB
Separation Modes:	reversed-phase and cation-exclusion
Column Dimenstions:	3.0 x 100 mm
Mobile Phase:	15% ACN with 0.2% of H3PO4
Detection:	UV 215 nm
Sample:	0.3 mg/ml
Injection:	1 uL
Flow rate:	0.6 mL/min

Analytes

Class of compounds:	Aromatic acid, Aromatic base, Drug, Pyridine
Nature of compounds:	Basic, Hydrophilic, Hydrophobic
Compounds:	Loratadine, Related Impurities