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

Patel, Kuldeep; Singh, Archana; Dubey, Richa

 
9786205639290: Stability Indicating Assay Method For Bisacodyl as Per ICH Guidelines: SIAMS FOR Bisacodyl
Couverture souple
ISBN 10 : 6205639297 ISBN 13 : 9786205639290
Editeur : LAP LAMBERT Academic Publishing, 2023

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.

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Éditeur
LAP LAMBERT Academic Publishing
Date d'édition
2023
Langue
anglais
ISBN 10 
6205639297
ISBN 13 
9786205639290
Reliure
Broché
Nombre de pages
104
Coordonnées du fabricant
non disponible
Personne responsable
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