Abstract
The objective of this present method is to develop simple, sensitive and precise HPLC method for the simultaneous determination of Aspirin and Rosuvastatin in pharmaceutical dosage form. The method was carried out using Greece C18 (4.6ID × 250mm; 5μm) column and mobile phase comprised of methanol and PDP buffer adjusted to pH 2.8 with Ortho phosphoric acid in proportion of ratio 70:30 v/v and degassed under ultrasonication. The flow rate was 1 mL/min and detection was carried out at 243 nm. The Retention time of Aspirin and Rosuvastatin were found to be 2.84 and 3.46 respectively.The validation of method was carried using ICH guidelines. The method was validated in terms of specificity, linearity, precision, accuracy, specificity, limit of detection, limit of quantitation and robustness. Linearity of Aspirin and Rosuvastatin were in the range of 75 to 375μg/mL (r2 = 0.9966) and 10 to 50μg/mL (r2 = 0.9987) respectively. The % recoveries of Aspirin and Rosuvastatin were found to be in between 99.48 % to 99.55 % for Aspirin and 98.001 % to 100.93 % for Rosuvastatin respectively. The method was also applied for the determination of Aspirin & Rosuvastatin in the presence of their degradation products formed under variety of stress conditions. Degradation products produced as a result of stress studies did not interfere with the detection of Aspirin and Rosuvastatin and the assay can thus be considered stability indicating. The proposed method is suitable for the routine quality control analysis for simultaneous determination of Aspirin and Rosuvastatin in bulk and pharmaceutical dosage form.
