VALIDATED RP-HPLC METHOD FOR DETERMINATION OF ROSUVASTATIN CALCIUM IN BULK AND PHARMACEUTICAL FORMULATION
AbstractA rapid, sensitive and specific RP-HPLC method was developed and validated for determination of Rosuvastatin Calcium in bulk and tablet dosage form. Chromatography was carried out on a Enable C18G (250 x 4.6 mm i.d.,5µ) column using filtered and degassed mixture of acetonitrile and water in the ratio of 75:25 % v/v as mobile phase at a flow rate of 0.6 ml/min and effluent was monitored at 252 nm. The method was linear over the concentration range of 5 – 40 µg/ml with a correlation coefficient of 0.999. The retention time of the drug was 3.097 mins. The proposed method was validated by determining sensitivity, accuracy, precision, robustness studies. The developed method was effectively applied to tablets of Rosuvastatin Calcium and the % assay of the drug was found to be 99.98 %. The method is simple, rapid, accurate, precise and reproducible and hence can be applied for routine quality control analysis of Rosuvastatin Calcium in pure and tablet dosage form.
Article Information
31
2913-17
406
2088
English
Ijpsr
Hemant Kumar T.*, Swathi Sri D., Vara Prasada Rao K. and Srinivasa Rao Y.
Department of Pharmaceutical Analysis and Quality Assurance, Vignan Institute of Pharmaceutical Technology, Visakhapatnam, Andhra Pradesh, India
hemkar_pharma@yahoo.co.in
16 November, 2014
12 February, 2015
18 March, 2015
10.13040/IJPSR.0975-8232.6(7).2913-17
01 July, 2015
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