Monday , 28 September 2020

Analytical Method Development and Validation for The Simultaneous Estimation of Rosuvastatin and Clopidogrel by RP-HPLC Method

B.Geetha Madhuri1, Dr. Gampa Vijay Kumar2
1KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
2Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.

ABSTRACT
A new method was established for simultaneous estimation of Rosuvastatin and Clopidogrel by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Rosuvastatin and Clopidogrel by using:   Agilent C18 (4.6 x 150mm, 5mm) , 5m column in gradient mode using mobile phase composition of Methanol: Phosphate buffer PH 4(60:40) with flow rate of 0.8ml/min at 254nm. detection wavelength was 254nm. The instrument used was WATERS, software: Empower, 2695 separation module. 2996 PDA detector., Empower-software version-2. The retention times were found to be 2.972 mins and 3.548 mins. The % purity of Rosuvastatin and Clopidogrel was found to be 101.27% and 99.97% respectively. The system suitability parameters for Rosuvastatin and Clopidogrel such as theoretical plates and tailing factor were found to be 4668, 1.3 and 6089 and 1.2, the resolution was found to be 6.0. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study n Rosuvastatin and Clopidogrel was found in concentration of 20 µg/ml and 20 µg/ml respectively coefficient (r2) was found to be 0.99932 and 0.99916 % recovery was found to be 0.23793 and 0.5232 %RSD for repeatability was 0.2 and 0.2, % RSD for intermediate precision was 0.2 and 0.1respectively. The precision study was precise, robust, and repeatable.LOD value was 3.041 and 9.79, and LOQ value was 3.08 and 10.37 respectively.
Keywords: Agilent C18, Rosuvastatin and Clopidogrel, RP-HPLC

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