Development of Rapid and Validated RP-HPLC Method for Concurrent Quantification of Rosuvastatin and Aspirin form Solid Dosage Form

Abstract:

Background: Combination of aspirin and rosuvastatin has been successfully used for the treatment of hyperlipidemia. Objective: The objective of the project was to establish a rapid, accurate and precise liquid chromatographic method for the concurrent quantification of aspirin and rosuvastatin from solid dosage form. Methodology: The analytes were successfully separated on chromolith C18 monolithic column, using 20mM phosphate buffer (pH. 3): acetonitrile: methanol in a proportion of 50:20:30 by volume. Mobile phase was pumped at the flow rate of 2 ml/min and column temperature was set at 25^OC. For recording, the response of both analytes, 240 nm wavelength was selected. Results: The newly proposed HPLC technique was validated as per the ICH guidelines. Both the analytes along with internal standard, losartan were separated within 2 min. The method showed good linearity in the concentration range of 10 to 150 μg/ml and 1 to 15 μg/ml for aspirin and rosuvastatin respectively with good correlation coefficient (r2 ≤ 0.99). The LOD and LOQ were also determined and were 0.1 and 0.3 μg/ml for aspirin and 0.23 and 0.64 μg/ml for rosuvastatin respectively. The percent relative standard deviation for intraday and intraday were less than 2% for both the analytes. The percent recovery for aspirin and rosuvastatin was found to be in the range of 98.89 to 99.73 and 99.25 to 100.75 respectively, with percent relative standard deviation and bias less than 2%. Conclusion: No signification difference was observed between suggested method and earlier reported HPLC procedure with photo diode detector method, in the results. Hence, the established HPLC technique could be adopted for repetitive quality assurance of aspirin and rosuvastatin from formulations.

Key words: RP-HPLC, Simultaneous determination, Rosuvastatin, Aspirin, Monolithic column.