Ibandronic acid

HPLC Analysis of Ibandronic, Etidronic and Zoledronic Acids on Amaze HD Column in HILIC and Anion-Exclusion Modes
Application description

This HPLC method details the separation of Ibandronic acid, Etidronic acid, and Zoledronic acid using an Amaze HD Column, employing both Hydrophilic Interaction Liquid Chromatography (HILIC) and anion-exclusion modes for optimal separation. Ibandronic Acid: Ibandronic acid belongs to the bisphosphonate class of drugs used in the treatment of osteoporosis and bone metastasis. It is highly water-soluble and contains two phosphonic acid groups, which impart strong acidic properties. Etidronic Acid: Etidronic acid is another bisphosphonate compound utilized in the treatment of various bone disorders. It is water-soluble and possesses phosphonic acid functional groups, contributing to its acidic nature and interaction with chromatographic stationary phases. Zoledronic Acid: Zoledronic acid is a potent bisphosphonate drug used for the treatment of osteoporosis and bone-related conditions. It exhibits high water solubility and contains phosphonic acid groups, rendering it acidic and suitable for chromatographic separation. The Amaze HD Column is chosen for its ability to handle polar and charged compounds effectively. In HILIC mode, the column facilitates retention and separation based on the hydrophilicity of the analytes, while in anion-exclusion mode, it selectively excludes negatively charged species, allowing for separation based on differences in charge and size. By utilizing this HPLC method, precise separation and quantification of Ibandronic, Etidronic, and Zoledronic acids can be achieved, facilitating their analysis in pharmaceutical formulations and biomedical research.

Conditions of Experiment
Column: Amaze HD
Separation Modes: HILIC, anion-exclusion
Column Dimenstions: 3x100 mm, 3 um, 100 A
Mobile Phase: ACN/water/ammonium formate pH 3
Detection: ELSD, 45*C
Sample: various-0.5 mg/ml
Injection: 3 uL
Flow rate: 0.6 ml/min
Analytes
Class of compounds: Drug, Organic acid
Nature of compounds: Acidic, Hydrophilic, Polar
Compounds: Ibandronic acid, Etidronic acid, Zoledronic acid
HPLC Analysis of Ibandronic Acid, Citric Acid and Mannitol on Amaze HD Mixed-Mode Column
Application description

Mannitol, ibandronic and citric acids are part of the formulation to reduce bone resorption, strengthen bones and treat Osteoporosis. Etidronic acid also prevents bone calcification. Citric acid is used as a preservative in the formulation. All three compounds are very polar in nature with citric and etidronic acids being acidic and mannitol being neutral. All three are not retained in RP chromatography. In HILIC, citric acid and etidronic acid can elute with a poor peak shape due to unspecified secondary interactions. We have developed a robust HILIC/anion-exclusion method for separation of these polar compounds. This method is compatible with major detection techniques for such compounds with no UV activity. (ELSD, CAD, RI and MS). The method can be used for analysis of polar acidic, basic and neutral compounds in HILIC, cation-exchange and anion-exclusion modes. The retention time is controlled by the amount of acetonitrile, buffer pH and buffer concentration. It is recommended to use salt buffer to achieve better retention and elution control.

Conditions of Experiment
Column: Amaze HD
Separation Modes: HILIC, anion-exchange
Column Dimenstions: 4.6x50 mm, 5 um, 100A
Mobile Phase: ACN/water/Buffer
Detection: ELSD, 50°C
Sample: 2 mg/ml
Injection: 2 uL
Flow rate: 1 ml/min
Analytes
Class of compounds: Drug, Organic acid, Preservative, Sugar
Nature of compounds: Acidic, Hydrophilic, Neutral, Polar
Compounds: Ibandronic acid, Citric acid, Mannitol