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Development and Validation of RP-HPLC Method for the Estimation of Rosuvastatin in Bulk and Pharmaceutical Dosage Form

Author(s): A. Lakshmana Rao and D. Suneetha

A simple, rapid, sensitive, reproducible and precise high performance liquid chromatographic method has been developed for the estimation of rosuvastatin in pure form as well as in pharmaceutical dosage form. In this method, RP-C18 column (100 mm x 4.6 mm I.D., 3 µm particle size) with mobile phase consisting of 0.02M phosphate buffer pH 6.8 and acetonitrile in the ratio of 60 : 40 v/v in isocratic mode was used. The detection wavelength is 242 nm and the flow rate 0.6 mL/min. The linearity was found in the range of 20-100 µg/mL and shows a correlation coefficient of 0.994. The retention time of the drug was 3.424. The proposed method was validated by determining sensitivity, accuracy, precision and linearity. The proposed method is simple, fast, accurate, precise and reproducible and hence, it can be applied for routine quality control analysis of rosuvastatin in pure and tablet dosage form.

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