Abstract

ANALYTICAL METHOD DEVELOPMENT AND HPLC METHOD VALIDATION FOR CHLORPHENIRAMINE MALEATE IS AN ACTIVE PHARMACEUTICAL INGREDIENT

Buyya Shyam Sunder and Ashutosh Kumar Mittal*

Abstract

Design, synthesis of chlorphenamine maleate has one asymmetric carbon atom, exists as racemic mixture of R & S forms and does not show optical rotation. It is a histamine H1 receptor antagonist used as an antihistamine. The first method of drug which involves absorbance measurement at 235 nm and Linearity was obtained in the range of 2- 30 μg/mL. Chromatographic separation was achieved using HPLC and the method was carried out on a kromasilC18 column has been developed with a mobile phase consisting of (10:90 v/v) methanol: 1 mL of hydrochloric acid in 2 L of water (pH 5.3 with orthophosphoric acid) at flow rate of 1.0 mL /min using UV detection at 235nm and The retention times of was about min 8 min. The described method was linear over a concentration range of 200-500 μg/mL with a correlation coefficient of 0.999 and the accuracy between 98.12-101.53%. The method was successfully applied for the estimation of drugs in formulation with high accuracy. Thus the developed method is simple, rapid, precise, selective, reproducible and accurate which is useful for the determination of of Chlorpheniramine Maleate in API.

Keywords: HPLC, Chlorpheniramine, Maleate, 2-chloro-N,N-dimethylethanamine.