DEVELOPMENT AND VALIDATION OF A NOVEL STABILITY INDICATING RP-HPLC ASSAY METHOD OF SOLIFENACIN SUCCINATE IN TABLET FORMULATION
M. Madhu Kiran* and C. Rambabu
ABSTRACT
A novel RP-HPLC assay method has been established for solifenacin succinate in pharmaceutical dosage forms. Successful separation of the solifenacin succinate was achieved on a Hiber R C-18 column (250mm × 4.6 mm i.d. with particle size of 5μm with potassium dihydrogen phosphate buffer (pH 2.5±0.05) and acetonitrile in the ratio of 60:40(%v/v) as mobile phase at a flow rate of 1.0ml/min . A calibration graph was obtained over six different concentrations in the range of 10-60μg/ml exhibiting regression equation of y = 3733.651x + 1358.6 (r2= 0.9997) for solifenacin succinate that revealed an excellent correlation exists between peak area and concentration of drug within the concentration range indicated above LOD and LOQ for solifenacin succinate are found to be 0.54μg/ml and 1.80μg/ml respectively. The developed RP-HPLC method had effectively separated solifenacin succinate from their degradation products, making it stability-indicating. Suitability of this method for the quantitative determination of the solifenacin succinate was proved by validation in accordance with the requirements of International Conference on Harmonization (ICH) guidelines.
Keywords: Solifenacin succinate, Stability Indicating Studies, Method Validation, HPLC Determination.
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