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Abstract

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

Jegan Jayabalan*, Rajagopal K and Dr. Ashraf Ali

ABSTRACT

A simple, precise and accurate method was developed and validated for dissolution of Solifenacin succinate in tablets. An isocratic HPLC analysis was developed on Inertsil ODS 3V (150 mm X 4.6 mm), 5 μm. The compound was separated with the mixture of Ammonium formate buffer pH 4.5 (the pH of the buffer solution was adjusted with diluted formic acid) and acetonitrile in the ratio of 65:35 v/v as the mobile phase at flow of 1.5 mL per minute. UV detection wasperformed at 215 nm. The retention time was found to be5.0 minute. The system suitability parameters such as theoretical plate count, tailing and percentageRSD between six standard injections were within the limit. The method was validated according toICH guidelines. Calibration was linear over the concentration range of 10- 120% of test concentration as indicatedby correlation coefficient (r) of 0.999. The robustness of the method was evaluated by deliberatelyaltering the chromatographic conditions. The developed method can be applicable forroutine quantitative analysis.

Keywords: ICH, in vitro dissolution, Method validation,Solifenacin succinate.


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