Friday , 26 February 2021

RP HPLC Method Development and Validation of Bicaultamide and Simvastatin in Bulk and Pharmaceutical Dosage Forms

C. Srinavya*1, P. Sowjanya2, Dr. Gampa Vijaya Kumar3
1,2KGR Institute of Technology and Management,   Rampally,   Kesara,   Rangareddy, Telangana, India,

3Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India

A new method was established for simultaneous estimation of Bicalutamide and Simvastatin by RP-HPLC method.  The chromatographic conditions were successfully developed for the separation of Bicalutamide and Simvastatin by using Zodiac sil C18 (4.6×150mm) 5µ column, flow rate was 1.0mL/min, mobile phase ratio was Methanol: sodium taurocholate (70:30%v/v), detection wave length was 258nm.  The instrument used was Shimadzu LC-20 AD, SPD-M20A diode array detector, LC 20 software.  The retention times were found to be 2.170 mins and 3.634mins. The analytical method was validated according to ICH guidelines (ICH, Q2(R1)). The linearity study for Bicalutamide and Simvastatin was found in concentration range of 1μg-5μg and 100μg-500μg and correlation coefficient (r2) was found to be 0.999 and 0.999, % mean recovery was found to be 100.0% and 100.5%, %RSD for repeatability was 1.9 and 1.5, % RSD for intermediate precision was 1.6 and 0.8 respectively.  LOD value was 3.041 and 3.08, and LOQ value was 9.79 and 10.37 respectively.  Hence the suggested RP-HPLC method can be used for routine analysis of Bicalutamide and Simvastatin in Quality Cont

Keywords: Zodiac sil C18, Bicalutamide and Simvastatin, RP-HPLC

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