DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF ATORVASTATIN AND ASPIRIN IN BULK COMBINED TABLET DOSAGE FORM

A New RP-HPLC Method for the Simultaneous Estimation of Atorvastatin and Aspirin in bulk and its Pure and Pharmaceutical Dosage Form as per ICH Guidelines. The Present work was to develop a simple, fast, accurate, precise, reproducible,Reverse Phase High Performance Liquid Chromatographic Method forsimultaneous estimation of Atorvastatin and Aspirinin pure and combined dosage form. Chromatographic separation was done usingSymmetry ODS C18 column having dimension of 4.6×250mm having particle size of 5.0µm, with mobile phase consisting of Acetonitrile: Methanol in the ratio 65:45v/v, flow rate was adjusted to 1ml/min and detection wavelength at 256nm. The retention times of Atorvastatin and Aspirinwas found to be 2.256 and 5.427 mins. The proposed method has been validated foraccuracy, precision, linearity; robustness and range were within the acceptancelimit according to ICH guidelines. Linearity for Atorvastatin and Aspirinwas found in range of 6µg-14µg and 18µg-42µg and correlation coefficient was foundto be 0.999 and 0.999% RSD for intermediate precision was found to be 0.5 and 0.3, for repeatability was 0.4 and 0.1, % mean recovery for Atorvastatin and Aspirin was found to be 101.326% and 100.501% respectively. The method wasfound to be robust even by change in the mobile phase ±2% and in more and less flowconditions. The developed method can be successfully employed for the routineanalysis of Atorvastatin and Aspirinin bulk and Pharmaceutical dosageforms. Keywords:Atorvastatin and Aspirin, RP-HPLC, Validation, Accuracy.