Simple, Rugged, and Accurate New Method for the Assay of Risedronate in Drugs

Thermo Fisher Scientific Inc have announced a new method that exceeds the US Pharmacopeia (USP) monograph specifications for risedronate sodium analysis. This method is based on an anionexchange separation with a 4 x 250mm Thermo Scientific Dionex IonPac AS7 (USP L48) column using edetate disodium (EDTA) eluent to resolve risedronate from related compounds. Application Note 289: Evaluation of the USP Risedronate Sodium Assay demonstrates the linearity, detection limits, precision, and accuracy of the assayed amount of risedronate in the drug substance and drug product (Actonel, 35mg tablets). The results of this study show the method to be simple, rugged, and accurate, thus making it suitable for use by quality control labs to ensure that the drug meets approved specifications.

The test results of this new method meet or exceed the USP monograph specifications for each tested variable in the range. The method separates risedronate in <15 min, leaving it well resolved from related compounds A and C. This study also proves method ruggedness by varying the column temperature, eluent pH, and using different Dionex IonPac™ AS7 columns from the same lot.