A RAPID RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF SOLIFENACIN SUCCINATE IN TABLETS
Keywords:
Nil, Solifenacin succinate, Method development, ValidationAbstract
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; 5μ), 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 10-30μg/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 7.65μg/ml and 23.19μg/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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References
Rami Reddy BV, Srinivasa Reddy B, Raman NVVSS, Subhash Reddy K, Rambabu C. Development and validation of a specific stability indicating High Performance Liquid Chromatographic methods for related compounds and assay of Solifenacin Succinate. J Chem 2013;1-10.
Desai D, Patel G, Shukla N, Rajput S. Development and validation of stability-indicating HPLC method for solifenacin succinate: isolation and identification of major base degradation product. Acta Chromatographica 2012;24(3):399–418.
Annapurna MM, Sowjanya G, Santosh Naidu M, Lohithasu D. A validated liquid chromatographic method for the determination of solifenacin succinate(urinary antispasmodic) in tablets. Chem Sci Transactions 2014;3(2):602-7.
Saroj Kumar R, Ravi kumar BVV, Ajaya Kumar P. A RP-HPLC method development and validation for the estimation of solifenacin in bulk and pharmaceutical dosage forms. Int J Bioassays 2012;01(12):210-3.
Radha Krishna S, Rao BM, Someswara Rao N. A validated rapid stability-indicating method for the determination of related substances in solifenacin succinateby ultra-fast liquid chromatography. J Chromatographic Sci 2010;48:807-10.
Vijayasree AV, Anantha kumar AD. Seshagiri rao BJVLN. Validated RP-HPLC method for the estimation of Solifenacin succinate in tablet dosage forms. Pharmanest 2013;4(2):206-12.
Nilesh D, Hussen SS, Vasanthraju SG, Karthik A, Udupa N. Development & validation of stability indicating HPLC method for determination of solifenacin in bulk formulations. Int J Pharm Pharm Sci 2011;3(1):70-4.
Divya teja G, Deva dasu CH, Srinivasa babu P, Ravi sankar P. Quantitative analysis of Solifenacin succinatein pharmaceutical dosage form using uv absorption spectroscopy. J Chem Pharm Sci 2013;6(3):195-8.
Seetharaman R, Lakshmi KS. Development and validation of first order derivative spectrophotometric method for estimation of Solifenacin succinatein pharmaceutical formulation. Int J Res Pharm Biomed Sci 2011;2(3):1052-7.
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use. Validation of Analytical Procedures: Text and Methodology ICH Q2 (R1); 2005.