Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ATROPINE SULFATE AND DIPHENOXYLATE HYDROCHLORIDE BY RP-HPLC METHOD IN PHARMACEUTICAL DOSAGE FORMS

P. Sitharamaraju*, M. Prasanthi Evangelin and Manohar Babu S.

ABSTRACT

The aim of the proposed method is to develop simple and accurate methods for the determination of Atropine sulfate and Diphenoxylate hydrochloride by RP-HPLC methods in pharmaceutical dosage forms. To develop simple, greater sensitive and faster elution method by RP-HPLC to reduce time of analysis based on the literature survey made. Main aim is to reduce the retention time of Atropine sulfate and Diphenoxylate hydrochloride. The scope of developing and validating analytical methods is to ensure suitable methods for a particular analyte of more specific, accurate, precise and robust. The main objective for this is to improve the conditions and parameters, which should be followed in the development and validation. The existing physicochemical methods are inadequate to meet the requirements; hence it is proposed to improve the existing methods and to develop new methods for the assay of Atropine sulfate and Diphenoxylate hydrochloride in pharmaceutical dosage forms adapting different available analytical techniques like HPLC.

Keywords: Atropine sulfate, Diphenoxylate hydrochloride, RP-HPLC, Method Development, Chromatographic Conditions, ICH guidelines.