ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ATORVASTATIN AND CLOPIDOGREL IN TABLET DOSAGE FORM BY RP-HPLC

*Shaik Mohammed Yusuf, Suruchi Samparna, Kolavali Yallareddy, B. Pavani, T. Sivakala

ABSTRACT

A new, simple, accurate and precise reversed phase high performance liquid chromatographic method was developed for the simultaneous quantitative estimation of Atorvastatin Calcium (ATOR) and Clopidogrel Bisulphate (CLOP) in combined capsule dosage form. The method was based on reversed phase liquid chromatography and separation was achieved on a Std kromasil (150 x 4.6 mm, 5). The Eluent was monitored by measuring the absorbance at wavelength 240 nm using a mixture of methanol and 0.01N Sodium dihydrogen ortho phosphate in the ratio of 50:50 (v/v) at pH 4 with a flow rate of 1.0 mL min-1. The Calibration curves were found to be linear in the concentration range of 5-30 μg mL-1 and 37.5-225 μg mL-1 for ATOR and CLOP respectively. The proposed method was validated by testing for its linearity, recovery, repeatability and it was successfully employed for the rapid, specific and sensitive simultaneous quantitative estimation of Atorvastatin Calcium and Clopidogrel Bisulphate in capsules.

Keywords: Atorvastatin, Calcium, Clopidogrel Bisulphate, RP-HPLC, Validation.