Stability Indicating Assay Method For Bisacodyl as Per ICH Guidelines - Patel, Kuldeep;Singh, Archana;Dubey, Richa
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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…mehr

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Produktbeschreibung
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.
Autorenporträt
Dr. Kuldeep Singh Patel, Ph.D, M.Pharm, B.Pharm é Director e Professor no Instituto de Investigação e Tecnologia-Farmácia do NRI, Bhopal, M.P Índia. O Dr. Patel foi galardoado como Melhor Professor por Swami Vivekananda Award. O Dr.Patel é Membro vitalício do IPGA, FIP, IPA, APTI. Publicou mais de 50 artigos de investigação internacional e 30 artigos nacionais.