Development and Validation of HPLC Method for Estimation of Some Active Analytes in Combined Dosage form an Application to In-vitro Dissolution Studies
Mayuri N. Deshmukh, Vaibhav Uplanchiwar, V. M. Thakare, Namrata S. Mane, S. Gaikwad, N. Dighade, Hina. Mehta, R. Bakal, Prashant R. Umate
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Abstract
This paper describes a new, simple, accurate and economical method of development and validation of HPLC method for the assessment of dicyclomine hydrochloride with omeprazol magnesium combine dosage form. The method development trial was carried out initially using C8 (100×0.46×3.5 μm) and C18 GraceSmart (250×4.6×5 μm) as stationary phase and acetate buffer (pH 4.5) and methanol as mobile phase in proportion 60:40v/v. The optimized conditions of factors were sample size 50 μL and wavelength (λmax) 215 nm. The developed method was then applied to in-vitro dissolution studies for the dicyclomine hydrochloride and omeprazole magnesium. As per ICH guidelines, stability testing was done. The estimated method can be used to analyze the pharma industries’ products.
期刊介绍：
INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE is a quarterly international journal publishing the finest peer-reviewed research in the field of Pharmaceutical Quality Assurance and Pharmaceutical Analysis on the basis of its originality, importance, disciplinary interest, timeliness, accessibility, elegance, and surprising conclusions. IJPQA also provides rapid, authoritative, insightful and arresting news and interpretation of topical and coming trends affecting science, scientists and the wider public.
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