Development and Validation of a new improved RP-HPLC Method for estimation of Rosuvastatin calcium in Pharmaceutical dosage form

摘要

A reliable, sensitive, isocratic and simple RP-HPLC was developed and validated for assay of Rosuvastatin Calcium in tablets and for determination of content uniformity. Chromatography was achieved by Thermo scientific C_8 column, 250 x 4.6mm, particle size 5 μm with flow rate of 1.0ml/min. Detection was monitor at 248 nm. The mobile phase consisted of methanol: acetonitrile : water (40:40:20, v/v). Retention time of Rosuvastatin Calcium was found to be 3.427-and an overall analytical run time of approximately 5 minutes. The method was linear over concentration range of 140-260ug/ml (r~2 = 0.999). The limit of detection and quantification was 3.26 and 9.88 respectively. Accuracy (recovery) of Rosuvastatin Calcium was between 106.58%,100.18% and 102.81 %. The developed method was validated for accuracy, precision, ruggedness, robustness and stability of solution. The proposed method is accurate, simple, rapid, precise, time effective, reproducible and hence can be applied routine quality control estimation of Rosuvastatin Calcium in tablet dosage form. The results of validation parameters have been validated statistically and also by recovery studies.