Open AccessDevelopment and Validation of Stability-Indicating HPTLC Method for Determination of Solifenacin Succinate as bulk Drug and in Tablet Dosage Form
Author(s) -
Mrinalini C. Damle,
P. C. Rokade
Publication year - 2016
Publication title -
international journal of pharmaceutical sciences and drug research
Language(s) - English
Resource type - Journals
ISSN - 0975-248X
DOI - 10.25004/ijpsdr.2016.080405
Subject(s) - chromatography , dosage form , acetic acid , chemistry , methanol , hydrolysis , silica gel , high performance thin layer chromatography , materials science , thin layer chromatography , organic chemistry
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.