Abstract

ESTIMATION OF RELATED SUBSTANCES IN TRIMETAZIDINE DIHYDROCHLORIDE DRUG SUBSTANCE BY RP-HPLC

*S. Sri Lakshmi, B. Manjupriya, G. Sravya and S. Kalyani

Abstract

A simple, specific, sensitive, accurate, robust, precise, and stability indicating RP-HPLC method was developed and validated for the stability indicating analytical method development and validation for the determination of related substances of the Trimetazidine dihydrochloride drug substance. The method was developed by using potassium hydrogen phosphate buffer pH 4.0, acetonitrile as mobile phase by gradient pump mode. The column used for separation was Develosil ODS MG-5, (250 X 4.6 mm), 5μm, as it helps to achieve good separation between the related substances in the drug product with 1.2ml/min flow rate and PDA detection at 240nm. The retention time of Trimetazidine dihydrochloride is about 16.13 min and for related substances i.e., impurity-E, impurity-A, impurity-I, impurity-J, impurity-F, impurity-H, impurity-D, impurity-B, impurity-C were found to be 14.50 min, 19.40min, 21.60 min, 22.47 min, 22.78 min,28.38 min,29.46 min, 30.47 min, 31.11 min respectively. The validation was carried out on optimised method and obtained results were within the limits of acceptance criteria for all the parameters like System suitability, Specificity, Linearity, Accuracy, Precision, LOD, LOQ, Robustness and stability of the method has been checked by the forced degradation studies. Based on the above information the method can be used for the daily routine analysis.

Keywords: RP-HPLC, Trimetazidine dihydrochloride, Related Substances, Forced degradation studies.