Simultaneous estimation of rosuvastatin and aspirin by RP-HPLC in pharmaceutical formulations

Abstract

We intends to develop RP-HPLC method by simultaneous determination with simple, rapid, greater sensitivity and faster elution. The work is to establish a stability-indicating HPLC method for simultaneous determination of Rosuvastatin and Aspirin in combined dosage form. The validated method would be applicable in both formulation development and routine quality control analysis. The estimation of Aspirin and Rosuvastatin was done by RP-HPLC. The assay of Aspirin and Rosuvastatin was performed with tablets and the % assay was found to be 99.11 and 100.76 which shows that the method is useful for routine analysis. The linearity of Aspirin and Rosuvastatin was found to be linear with a correlation coefficient of 0.999 and 0.999, which shows that the method is capable of producing good sensitivity.

The acceptance criteria of precision is RSD should be not more than 2.0% and the method show precision 0.8 and 0.5 for Aspirin and Rosuvastatin which shows that the method is precise.

The acceptance criteria of intermediate precision is RSD should be not more than 2.0% and the method show precision 0.6 and 0.5 for Aspirin and Rosuvastatin which shows that the method is repeatable when performed in different days also.

The accuracy limit is the percentage recovery should be in the range of 97.0% - 103.0%. The total recovery was found to be 100.34% and 100.22% for Aspirin and Rosuvastatin. The validation of developed method shows that the accuracy is well within the limit, which shows that the method is capable of showing good accuracy and reproducibility.

The acceptance criteria for LOD and LOQ is 3 and 10.The LOD and LOQ for Aspirin was found to be 3.00 and 9.98 and LOD and LOQ for Rosuvastatin was found to be 3.02 and 10.00.