Quantitative estimation of Rosuvastatin in bulk and tablet dosage form by using area under curve method

Source of Support: , Conflict of Interest: None

Check

DOI: 10.4103/2231-4040.197331

Simple, precise and economical UV spectrophotometric method has been developed for the estimation of Rosuvastatin in pharmaceutical dosage form and bulk. Method applied was area under curve (AUC) in which area under curve was integrated in the wavelength range of 234.60-251.00 nm. Calibration curves were plotted for method by using instrumental response at selected wavelength and concentrations of analyte in the solution. Linearity for the detector response was observed in the concentration range of 2-12 µg/ml for the method. Tablet formulation was analyzed and % assay determined was 98.35%-102.07%. Accuracy and precision studies were carried out and results were satisfactory. The results of the analysis were validated statistically. Limit of detection and limit of quantitation was determined for methods. The methods were validated by following the analytical performance parameters suggested by the International Conference on Harmonization. All validation parameters were within the acceptable range. The developed methods were successfully applied to estimate the amount of Rosuvastatin in pharmaceutical formulation and bulk.

Keywords: Rosuvastatin, UV-spectrophotometry, Area under curve, Validation