Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE CHROMATOGRAPHIC PURITY OF SOLIFENACIN SUCCINATE IN TABLET DOSAGE FORM

Jegan Jayabalan*, Ashraf Ali and Rajagopal K.

ABSTRACT

A simple, precise and accurate chromatographic purity method was developed and validated for Solifenacin succinate in tablets. A gradient HPLC analysis was developed on Inertsil C8 (150 mm X 4.6 mm), 3 μm. The compounds were separated with the mixture of buffer pH 2.60 and acetonitrile as the mobile phase at flow gradient of 1.0 mL per minute and 1.3 mL per minute. UV detection was performed at 215 nm. The retention time was found to be 17.0 minute. The system suitability parameters such as s/n ratio, resolution, theoretical plate count, tailing and percentage RSD between six standard injections were within the limit. The method was validated according to ICH guidelines. Calibration was linear over the concentration range of LOQ-150% of test concentration as indicated by correlation coefficient (r) of 0.9999. The robustness of the method was evaluated by deliberately altering the chromatographic conditions. The developed method can be applicable for routine quantitative analysis.

Keywords: ICH, Purity, Method validation, Solifenacin succinate.