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International Journal of Pharmaceutical Chemistry and Analysis


Development and Validation of a Stability Indicating Assay Method Using Hplc for Determinrtion of a Model Drug in Bulk and Pharmaceutical Dosage Form


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Author Details : Vijay Bhosale1, *, AV. Chandewar2, A. P Dewani3, C K. Gadewar4

Volume : 2, Issue : 1, Year : 2015

Article Page : 34-37


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Abstract

 The aim of present work was to develop a RP-HPLC method for Determination of a model drug in bulk and pharmaceutical dosage form. Agilent Chromatographic system was optimized using a Hypersil BDS C18 column (250 x 4.60 x 5μm) with mobile phase comprising of 7.5 Phosphate buffer: Acetonitrile in the ratio of 300:700. The flow rate was adjusted to 2.0 ml/min with UV detection at 215 nm. DCL were eluted with retention times of 9.30± 0.3 min respectively. Beer’s Lambert’s Law was obeyed over the concentration ranges of 27.97- 51.94mcg/ml, for DCL. The high recovery and low coefficients of variation confirm the suitability of the method for quqntitative analysis of drug in a liquid dosage form. Statistical analysis proves that the method is sensitive and significant for the analysis of DCL in pure and in pharmaceutical dosage form without any interference from the excipients. The method was validated in accordance with ICH guidelines.

 

Keywords: Dicyclomine Hydrochloride; Stability indicating study; HPLC.

How to cite : Bhosale1 V, *, Chandewar2 A, Dewani3 A P, Gadewar4 C K, Development and Validation of a Stability Indicating Assay Method Using Hplc for Determinrtion of a Model Drug in Bulk and Pharmaceutical Dosage Form. Int J Pharm Chem Anal 2015;2(1):34-37

Copyright © 2015 by author(s) and Int J Pharm Chem Anal. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0) (creativecommons.org)