Method Development and Validation for the Determination of Ibandronic Acid in Solid Dosage Form by RP-HPLC

A high-performance liquid chromatographic method has been developed for the analysis of Ibandronic acid¹⁰ in solid dosage form¹. The mobile phase consisting of EDTA and Hexane sulphonic acid buffer by adjusting pH (pH 2.5) and acetonitrile in ratio of (95:5% v/v) was delivered at the flow rate of 1.0 mL/min and UV detection was carried out at 195 nm¹. The separation was achieved using C18 reverse-phase column (250 X 4.6 mm I.D., particle size 5μm)⁷. The method was linear over the concentration range for Ibandronic acid. The analytical recovery obtained was 99.88%. The validation of method carried out as per ICH guidelines⁴. The described HPLC method was successfully employed for the analysis of pharmaceutical formulations containing Ibandronic acid in solid dosage form and can be employed for bioequivalence study in future for the same formulations.