Ion exchange chromatographic determination of olpadronate, phosphate, phosphite, chloride and methanesulfonic acid

A method based on single column ion chromatography with UV detection was de veloped for purity testing and assay of monosodium olpadronate. The analyte aqueous solution is precipitated with methanol to enhance the impurities/o lpadronate molar ratio, thus improving purity determination at trace levels . The resulting solution is injected into a standard chromatographic system with UV detector in indirect mode with a Waters IC Pak HR column using dil uted nitric acid as the moblie phase. The method was fully validated accord ing to ICH guidelines for the determination of phosphite, phosphate, chlori de and methanesulfonic acid in olpadronate bring suitable for purity testin g and assay. (C) 2001 Elsevier Science B.V. All rights reserved.