{'fraction_non_alphanumeric': 0.02914798206278027, 'fraction_numerical': 0.02242152466367713, 'mean_word_length': 5.468599033816425, 'pattern_counts': {'":': 0, '<': 0, '<?xml version=': 0, '>': 0, 'https://': 0, 'lorem ipsum': 0, 'www.': 0, 'xml': 0}, 'pii_count': 0, 'substrings_counts': 0, 'word_list_counts': {'cursed_substrings.json': 0, 'profanity_word_list.json': 0, 'sexual_word_list.json': 0, 'zh_pornsignals.json': 0}}
DENSITOMETRIC EVALUATION OF STABILITY – INDICATING HPTLC METHOD FOR THE ANALYSIS OF DARIFENACIN HYDROBROMIDE IN BULK AND IN TABLET DOSAGE FORM

A simple and sensitive thin-layer chromatographic method has been established for analysis of darifenacin hydrobromide in pharmaceutical dosage form. Chromatography on silica gel 60 F254 plates using toluene:acetone:methanol (6:3:3 v/v/v) as the mobile phase furnished compact spots at Rf 0.34 ± 0.02. Densitometric analysis was performed at 286 nm. To show the specificity of the method, darifenacin hydrobromide was subjected to acid, base, neutral hydrolysis, oxidation, photolysis, and thermal decomposition. The drug underwent degradation only under oxidative condition; also the degraded product was well separated from pure drug with significantly different Rf value. Linear regression analysis revealed a good linear relationship between peak area and amount of darifenacin hydrobromide in the range of 50–450 ng/spot. The minimum amount of darifenacin hydrobromide that could be authentically detected and quantified was 30.36 and 90.79 ng/spot, respectively. The method was validated, in accordance with ICH guidelines for precision, accuracy, and robustness. As the method could effectively separate the drug from its degradation products, it can be regarded as stability indicating.