DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ASPIRIN AND ROSUVASTATIN CALCIUM IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORM BY AREA UNDER CURVE METHOD

The work deals with the simultaneous estimation of aspirin and rosuvastatin calcium in bulk drug and pharmaceutical dosage form. A specific, rapid and simple UV spectrophotometric method with good sensitivity was developed and validated. Method was based on application of area under curve at selected wavelength range, 221-230 nm and 241-253 nm. Methanol was used as a solvent for this method. The calibration curve was linear for both the drugs in the range 5 - 20 µg/ml and 3.5 - 17.5 µg/ml for ASP and ROSU, respectively. The method was validated according to ICH guideline and recovery studies were carried out. Method was found to be accurate, precise and reproducible. This method was applied to the assay of the drugs in marketed formulation, which were found to be in the range of 101 to 102% of the labeled value for both ASP and ROSU. Hence, the method herein described can be successfully applied in quality control of combined pharmaceutical dosage forms.