Stability Indicating Assay Method For Bisacodyl as Per ICH Guidelines: SIAMS FOR Bisacodyl

Patel, Kuldeep; Singh, Archana; Dubey, Richa

ISBN 10: 6205639297 / ISBN 13: 9786205639290

Edité par LAP LAMBERT Academic Publishing, 2023

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N° de réf. du vendeur 18396038375

Détails bibliographiques

• Titre: Stability Indicating Assay Method For Bisacodyl as Per ICH Guidelines: SIAMS FOR Bisacodyl
• Éditeur: LAP LAMBERT Academic Publishing
• Date de parution: 2023
• Langue: anglais
• ISBN à 10 chiffres: 6205639297
• ISBN à 13 chiffres: 9786205639290
• Reliure: Couverture souple
• État de l'article: New

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Synopsis

In this study, it is possible to develop to selective and validated stability-indicating HPLC assay method for bisacodyl on a C18 column, which could separate the drug and its degradation products formed under a variety of stress conditions. Bisacodyl was found to be less stable in solution state, whereas it was comparatively much stable in solid state. The method proved to be simple, accurate, precise, specific and selective. Hence it is recommended for analysis of the drug and degradation products in stability samples by the industry.Indirectly, the study highlights the benefit of the use of ICH stress testing approach in establishment of complete degradation of drugs. It is hoped that this report on stability-indicating method of bisacodyl would be helpful for the multiple generic manufacturers of the drug around the globe by saving them from unnecessary repetition of same studies.