DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING HPTLC METHOD FOR DETERMINATION OF SOLIFENACIN SUCCINATE AS BULK DRUG AND IN TABLET DOSAGE FORM
Abstract
A new simple, stability- indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for estimation of Solifenacin succinate in bulk and in tablet dosage form. The optimized mobile phase was Methanol: Water: Glacial acetic acid (9:1:0.1v/v/v) with UV detection at 216 nm. The retention factor for Solifenacin succinate was found to be 0.49 ± 0.03. The drug was subjected to stress conditions of hydrolysis under different pH conditions, oxidation, photolysis and thermal degradation as per ICH guidelines. Results were found to be linear in the concentration range of 2000-10000ng band-1.
Keywords:
Solifenacin succinate, HPTLC, Forced degradation, ValidationDOI
https://doi.org/10.25004/IJPSDR.2016.080405References
1. The Merck Index. An Encyclopedia of Chemicals, Drugs and Biologicals, 14th edition, 2006, pp 1494.
2. http://en.wikipedia.org/wiki/Solifenacin (Jan 2016)
3. Shaik R, Puttagunta S. Bioanalytical method for quantification of Solifenacin in rat plasma by LC-MS/MS and its application to pharmacokinetic study. Journal of Analytical Science and Technology. 2014; 5(35): 1-8.
4. Kumar A, Mohan T. A Rapid RP-HPLC Method Development and Validation for the Quantitative Estimation of Solifenacin Succinate in Tablets. International Journal of Pharmacy and Pharmaceutical Sciences. 2014; 6(10): 201-204.
5. Kumar D, Vijayasree V. Validated RP-HPLC Method For The Estimation of Solifenacin Succinate In Tablet Dosage Forms. Pharmanest. 2013; 4(2): 206-212.
6. Reddy BV, Reddy BS. Development and Validation of a Specific Stability Indicating High Performance Liquid Chromatographic Method for Related Compounds and Assay of Solifenacin Succinate. Hindawi Publishing Corporation Journal of Chemistry 2013: 1-10.
7. Desai N, Syed S. Development & Validation of Stability Indicating HPLC Method for Determination of Solifenacin in Bulk Formulations. International Journal of Pharmacy and Pharmaceutical Sciences. 2011; 3(1): 70-74.
8. Desai D, Patel G. 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.
9. Rao BM, Radhakrishna S. A Validated Rapid Stability-Indicating Method for the Determination of Related Substances in Solifenacin Succinate by Ultra-Fast Liquid Chromatography. Journal of Chromatographic Science. 2010; 48: 806-810.
10. Wankhede SB, Somani K. Stability Indicating Normal Phase HPTLC Method for Estimation of Alfuzosin and Solifenacin in Pharmaceutical Dosage Form. International Journal of ChemTech Research. 2011: 3(4): 2003-2010.
11. Desai D, Mehta G. Development and validation of Stability Indicating HPTLC Method of Solifenacin Succinate. Asian Journal of Pharmaceutical and Biological Research. 2011; 1(3): 310-316.
12. Biradar SP, Kalyankar TM. Stability Indicating HPLC Method Development: Review. Asian Journal of Medicinal and Analytical Chemistry.2014; 1(1): 21-26.
13. Blessy M, Patel R. Development of forced degradation and stability indicating studies of drugs—A review. Journal of Pharmaceutical Analysis. 2014; 4(3): 159–165.
14. Damle M, Kardile K. Stability Indicating UV Spectrophotometric Method for Determination of Dronedarone Hydrochloride. International Journal of Pharmaceutical Sciences and Drug Research 2015; 7(1): 116-119
15. International Conference on Harmonization (ICH), Stability Testing: Photostability Testing of New Drug Substances and Products, Q1B, Nov. 1996.
16. International Conference on Harmonization (ICH), Stability testing of new drug substances and products, Q1A (R2), (2003).
17. International Conference on Harmonization (2005) ICH harmonized tripartite guideline Validation of analytical procedures: text and methodology Q2 (R1) ICH, Geneva, Nov (2005).
2. http://en.wikipedia.org/wiki/Solifenacin (Jan 2016)
3. Shaik R, Puttagunta S. Bioanalytical method for quantification of Solifenacin in rat plasma by LC-MS/MS and its application to pharmacokinetic study. Journal of Analytical Science and Technology. 2014; 5(35): 1-8.
4. Kumar A, Mohan T. A Rapid RP-HPLC Method Development and Validation for the Quantitative Estimation of Solifenacin Succinate in Tablets. International Journal of Pharmacy and Pharmaceutical Sciences. 2014; 6(10): 201-204.
5. Kumar D, Vijayasree V. Validated RP-HPLC Method For The Estimation of Solifenacin Succinate In Tablet Dosage Forms. Pharmanest. 2013; 4(2): 206-212.
6. Reddy BV, Reddy BS. Development and Validation of a Specific Stability Indicating High Performance Liquid Chromatographic Method for Related Compounds and Assay of Solifenacin Succinate. Hindawi Publishing Corporation Journal of Chemistry 2013: 1-10.
7. Desai N, Syed S. Development & Validation of Stability Indicating HPLC Method for Determination of Solifenacin in Bulk Formulations. International Journal of Pharmacy and Pharmaceutical Sciences. 2011; 3(1): 70-74.
8. Desai D, Patel G. 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.
9. Rao BM, Radhakrishna S. A Validated Rapid Stability-Indicating Method for the Determination of Related Substances in Solifenacin Succinate by Ultra-Fast Liquid Chromatography. Journal of Chromatographic Science. 2010; 48: 806-810.
10. Wankhede SB, Somani K. Stability Indicating Normal Phase HPTLC Method for Estimation of Alfuzosin and Solifenacin in Pharmaceutical Dosage Form. International Journal of ChemTech Research. 2011: 3(4): 2003-2010.
11. Desai D, Mehta G. Development and validation of Stability Indicating HPTLC Method of Solifenacin Succinate. Asian Journal of Pharmaceutical and Biological Research. 2011; 1(3): 310-316.
12. Biradar SP, Kalyankar TM. Stability Indicating HPLC Method Development: Review. Asian Journal of Medicinal and Analytical Chemistry.2014; 1(1): 21-26.
13. Blessy M, Patel R. Development of forced degradation and stability indicating studies of drugs—A review. Journal of Pharmaceutical Analysis. 2014; 4(3): 159–165.
14. Damle M, Kardile K. Stability Indicating UV Spectrophotometric Method for Determination of Dronedarone Hydrochloride. International Journal of Pharmaceutical Sciences and Drug Research 2015; 7(1): 116-119
15. International Conference on Harmonization (ICH), Stability Testing: Photostability Testing of New Drug Substances and Products, Q1B, Nov. 1996.
16. International Conference on Harmonization (ICH), Stability testing of new drug substances and products, Q1A (R2), (2003).
17. International Conference on Harmonization (2005) ICH harmonized tripartite guideline Validation of analytical procedures: text and methodology Q2 (R1) ICH, Geneva, Nov (2005).
Published
01-07-2016
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“DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING HPTLC METHOD FOR DETERMINATION OF SOLIFENACIN SUCCINATE AS BULK DRUG AND IN TABLET DOSAGE FORM”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 8, no. 4, July 2016, pp. 218-22, https://doi.org/10.25004/IJPSDR.2016.080405.
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How to Cite
“DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING HPTLC METHOD FOR DETERMINATION OF SOLIFENACIN SUCCINATE AS BULK DRUG AND IN TABLET DOSAGE FORM”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 8, no. 4, July 2016, pp. 218-22, https://doi.org/10.25004/IJPSDR.2016.080405.
