Determination of bisphosphonate drugs in pharmaceutical dosage formulations by ion chromatography with indirect UV detection.

Abstract

Application of ion chromatography (IC) to the analysis of non-chromophoric bisphosphonate drugs in pharmaceutical dosage formulations is described. The method is based on the use of single-column ion chromatography in conjunction with indirect UV detection that obviates the need for tedious chemical derivatization procedures. Diluted drug samples are chromatographed directly on a Waters IC-Pak HR anion-exchange column with dilute nitric acid (1.6-12 mM) as the mobile phase which exhibits a UV absorption maximum near 220 nm. Analyte detection is monitored by measuring the decrease in absorption of the mobile phase. The IC method has been validated and shown to be precise, accurate, specific and rugged for routine assay. Application of the method to the determination of alendronate sodium tablets, etidronate disodium injectable (which requires an eluent pH control for chromatographic resolution of active drug from chloride ions) and clodronate disodium injectable is presented. The performances of the Waters IC-Pak HR and several equivalent columns are also discussed.