A simple and reproducible method has been developed for Trimetazidine Hydrochloride by Reverse phase high performance liquid chromatography (RP-HPLC). The separationswere performed in C18 column at ambient temperature with a mobile phase of Methanol and Hexane-1Sulfonic Acid Sodium Salt, pH 3.0 adjusted with Phosphoric acid solution and flow rate of 1.2 mL/min. The wavelength for maximum absorbance was selected as 232 nm by the spectral scan of the Trimetazidine Hydrochloride standard solution in UV-VIS Spectrophotometer. The detection was done by using UV detector at 232 nm. The developed method was validated in complete compliance with the current regulatory guidelines by using well developed analytical method validation techniques and tools that comprises of the analytical method validation parameters like linearity, accuracy, method precision, specificity, system suitability and robustness. The proposed method's results were found to be satisfactory and are suitable for the determination of Trimetazidine Hydrochloride for routine quality control of drugs in bulk drug and formulation. The method was found to be linear with a regression coefficient value of 0.999 at a concentration of 80.0% – 120.0% of the Labelled amount of Trimetazidine Hydrochloride. The range was determined at 80%, 90%, 100%, 110% and 120% of the nominal test concentration for assay with acceptable accuracy (% Recovery: 99.51) and precision study (% RSD: 0.10) in five replicate analysis standard of Trimetazidine sample solution. The method showed good precision with a %RSD value of 0.10 for repeatability or intraday precision study and a mean %RSD value of 0.46 for intermediate precision or interday precision study. Accuracy was checked for replicate analysis of three concentration levels by the standard addition method. % recovery value obtained was 99.21-100.27 % with a % RSD of 0.73-1.02. Specificity was checked by comparing the peaks of standard and sample with excipients for the presence of any interference. The developed method was found to be robust with flow rate variation of 1 ml- 1.4 ml/min and column variation of 20 °C – 30 °C. System suitability parameters were checked for acceptance limit in terms of asymmetry, theoretical plates, tailing factor and relative standard deviation (%) of the five replicate injections in 20 µL value of the standardsolution at a specific concentration. which is useful for the routine determination of Trimetazidine in bulk drugs and its pharmaceutical dosage form. Further study on the degradation pathway of the compound will provide an idea about the stability indicating the nature of the method to discriminate the active constituent, Trimetazidine Hydrochloride from its related impurities and degradants.

Trimetazidine Hydrochloride, Myocardial metabolism modifier, HPLC, Method validation