Development and Validation of Simple and Convenient UV Spectrophotometric Methods of Trimetazidine in Five Different Solvent Systems

Simple, rapid, and reproducible UV spectrophotometric methods were developed and validated for the estimation of trimetazidine hydrochloride in bulk and pharmaceutical formulation. Spectral scan was conducted in the UV‐Vis range of 200–400 nm, and the quantification of trimetazidine was done at 230 nm in five distinct solvent systems. Phosphate buffer of pH 6.8, hydrochloric acid buffer of pH 2, a 50:50 mixture of phosphate buffer and methanol (50:50; v / v ), a 50:50 mixture of hydrochloric acid buffer and methanol (50:50; v / v ), and methanol were selected as solvent systems after completing the stability study for five consecutive days. Beer’s law was obeyed in the concentration range approximately 5–50 μ g∙mL −1 ( R 2 = 0.997). All validation parameters like linearity, sensitivity, precision, accuracy, specificity, and robustness were tested according to ICH guidelines. The limits of detection and quantification were determined to be between 0.3 and 1.7 μ g mL−1 and 1.12 and 3.70 μ g∙mL−1, respectively. The aforementioned techniques were directly implemented in the analysis of the commercial pharmaceutical formulations. The results revealed that the approach is easily reproducible, accurate, and precise with a value of relative standard deviation < 2 % , at the same time simple, economic, and less time‐consuming. Therefore, these methods can be properly employed for quantification of trimetazidine in bulk and pharmaceutical dosage forms, and among five solvent systems, two solvent systems (phosphate buffer and hydrochloric acid buffer) can be used for dissolution experiments.