A RAPID RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF SOLIFENACIN SUCCINATE IN TABLETS
Keywords:Nil, Solifenacin succinate, Method development, Validation
Objective: To develop an accurate, precise and linear Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method and validate as per ICH guidelines for the quantitative estimation of Solifenacin succinate (5mg) in tablets.
Methods: The optimized method uses a reverse phase column, Enable Make C18G (250 X 4.6 mm; 5Î¼), a mobile phase of triethylammonium phosphate buffer (pH 3.5): acetonitrile in the proportion of 30:70 v/v, flow rate of 1.0 ml/min and a detection wavelength of 210 nm using a UV detector.
Results: The developed method resulted in Solifenacin succinate eluting at 3.5 min. Solifenacin succinate exhibited linearity in the range 10-30Î¼g/ml. The precision is exemplified by relative standard deviation of 0.76%. Percentage Mean recovery was found to be in the range of 98â€102, during accuracy studies. The limit of detection (LOD) and limit of quantitiation (LOQ) was found to be 7.65Î¼g/ml and 23.19Î¼g/ml respectively.
Conclusion: A rapid, accurate, precise and linear RP-HPLC method was developed and validated for the quantitative estimation of solifenacin succinate in SOLITEN (5mg) tablets as per ICH guidelines and hence it can be used for routine analysis in various pharmaceutical industries.
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