Abstract
A precise method (in accordance with ICH guidelines) is developed for the simultaneous quantitative determination of Epigallocatechin gallate and Rosuvastatin Calcium in a combined pharmaceutical dosage form. The method was based on Ultra Performance Liquid Chromatography separation of the two drugs using 0.04M Potassium dihydrogen phosphate buffer: Acetonitrile: Methanol (45:25:30, v/v), pH 3.0, as a mobile phase. Areas were recorded at 245 nm for both the drugs and retention time was found to be 0.238 min and 0.753 min for Epigallocatechin gallate and Rosuvastatin Calcium, respectively at 1.0 mL min-1 flow rate. The selected chromatographic conditions were found to determine Epigallocatechin gallate and Rosuvastatin Calcium quantitatively in a combined dosage form without any physical separation. The method has been validated for linearity, accuracy and precision. Linearity was found over the range of 200-300 μg ml-1 and 4-6 μg ml-1 for Epigallocatechin gallate and Rosuvastatin Calcium respectively. The proposed method was found to be fast, accurate, precise, reproducible and rugged and can be used for a simultaneous analysis of these drugs in combined formulations.