DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF ROSUVASTATIN CALCIUM IN BULK AND TABLET DOSAGE FORM

M. Chandra Shekhar*, G. Raveendra Babu, S.C. Dinda, P.V. Sonthosh, P. Shwetha

A validated simple, sensitive, specific and precise RP-HPLC method was developed for the determination of Rosuvastatin in pure and pharmaceutical formulations. Method was carried on Symmetry C18 column (100 X 4.6 mm i.d., particle size 3.5um,ACE) using acetontrile: phosphate buffer as mobile phase in the ratio of 60:40v/v/. The detection was carried out at 243nm using Waters (2659) UV-Visible detector.The proposed method obeyed linearity in the range of 20-60 μg/mL and met all specifications as per ICH guidelines. Statistical analysis revealed that this method can be used in routine quality control studies of Rosuvastatin in pure and its pharmaceutical formulations.