Monday , 28 September 2020

Analytical Method Development and Validation for Dolutegravir and Rilpivirine in API and Combined Pharmaceutical Dosage Forms by RP-HPLC

Choppakatla Hanumath Satya Sai Srivatsava1, T. Rajesh2, Gampa Vijay Kumar3*
1KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
2KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
3Professor and Head, Dept.of Pharmacy, KGR InstituteofTechnology and Management, Rampally, Kesara, Rangareddy, Telangana, India.

ABSTRACT
New method was established for simultaneous estimation of Rilpivirine and Dolutegravir by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Rilpivirine and Dolutegravir by using ACE C18 column (4.6×150mm) 5µ, flow rate was 1.2 ml/min, mobile phase ratio was (70:30 v/v) methanol: Phosphate buffer pH 3 (pH was adjusted with orthophosphoric acid), detection wavelength was 240nm. The retention times were found to be 2.344 mins and 3.296 mins. The % purity of Rilpivirine and Dolutegravir was found to be 101.27% and 99.97% respectively. The system suitability parameters for Rilpivirine and Dolutegravir 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 Rilpivirine and Dolutegravir was found in concentration range of 50µg-250µg and 5µg-50µg and correlation coefficient (r2) was found to be 0.999 and 0.999, % recovery was found to be 99.56% and 99.48%, %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 3.17 and 5.68, and LOQ value was 0.0172 and 0.2125 respectively. Hence the suggested RP-HPLC method can be used for routine analysis of Rilpivirine and Dolutegravir in API and Pharmaceutical dosage form.
Keywords: ACE C18 column, Rilpivirine and Dolutegravir, RP-HPLC

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