Quantitative Determination Of Bisphosphonate Pharmaceuticals And Excipients By Capillary IC-MS

By Leo Jinyuan Wang and William C. Schnute, Thermo Fisher Scientific

Bisphosphonates are a group of compounds that are used as active pharmaceutical ingredients (APIs) to treat bone disorders including osteoporosis, Paget’s disease, and hypercalcemia. Typical methods for bisphosphonates analysis include liquid chromatography (LC) with derivatization and/or ion pairing, ion chromatography (IC), capillary electrophoresis (CE), and gas chromatography (GC) with derivatization. The reported analytical methodologies for bisphosphonates were summarized and compared in a review article published in 2008.12 This article concluded that for pharmaceutical purpose quality control (QC), IC with conductivity is “an obvious solution,” offering “simplicity, avoidance of derivatization steps, adequate sensitivity and simultaneous separation of ionic impurities.” The authors also indicated that mass spectrometry (MS) would be a sensitive approach, but the application to bisphosphonate analysis is limited due to the obvious incompatibility of the ion-pairing agent used in the mobile phase.