DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING HPTLC METHOD FOR DETERMINATION OF SOLIFENACIN SUCCINATE AS BULK DRUG AND IN TABLET DOSAGE FORM
Journal Title: International Journal of Pharmaceutical Sciences and Drug Research - Year 2016, Vol 8, Issue 4
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.
Authors and Affiliations
M. C. Damle, P. C. Rokade
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