Abstract : Ibandronic acid is a highly efficacious bisphosphonate that effectively impedes the process of osteoclast-mediated bone resorption in postmenopausal women with osteoporosis. Our investigation aimed to establish a cost-effective high-performance liquid chromatography (HPLC) method for the accurate and dependable quantification of Ibandronic Acid. It is imperative to note that this particular compound is not included in the official pharmacopoeial compendium. Employing a C18 column (Hypersil BDS recommended), the compound was isolated utilizing a mobile phase containing pentanesulfonic acid sodium salt, EDTA, TEA, and orthophosphoric acid. The flow rate was set at 1 mL/min, with detection wavelength at 200 nm. Employing a calibration curve, the amount of Ibandronic acid present in tablet form was determined. The methodology expounded in this research was validated in compliance with the International Council for Harmonisation (ICH) guidelines for various parameters, encompassing linearity, accuracy, precision, robustness, and specificity. The linearity of concentrations, specifically at 0.19, 0.32, 0.51, 0.64, 0.76, and 0.96 mg/mL, exhibited a strong correlation coefficient (r) of 0.999. Ibandronic Acid displayed a retention time of 4.58 ± 0.45 min. The specificity assessment indicated the absence of impurities. The Limits of Detection (LOD) and quantification (LOQ) values were determined to be 0.021026880 and 0.06371782, respectively. This methodology can be effectively utilized for routine quality control evaluation in the analysis of Ibandronic Acid in tablet preparations..

Keyword : Bisphosphonate, HPLC, Ibandronic Acid, Mobile Phase, Osteoclast, Validation