High performance liquid chromatographic method validation for determination of rosuvastatin calcium in tablet dosage forms

ABSTRACT

A precise, sensitive and quick High Performance Liquid Chromatographic [HPLC] method for the determination of rosuvastatin calcium in bulk and tablet dosage forms has been validated. The chromatographic scheme involved Sil-20A auto sampler, LC-20A pump, SPD-20A UV/visible detector with separation attained by C18 column at 40oC temperature through a mobile phase of acetonitrile and buffer [5050] at a flow rate of 1.0ml/min. The method is precise [%RSD for intra-day and inter-day extended between 1.06-1.54% and 0.103-1.78%] and linear [r[2]=0.9997]. Limit of detection and quantification [LOD and LOQ] of the adopted method were 0.78 and 1.56Mug/ml. The proposed HPLC method was established to be sensitive, precise and swift that can be proficiently adopted in quality control/quality assurance laboratories for predictable investigation of the bulk and oral solid dosage forms of rosuvastatin calcium