Wednesday , 27 October 2021

RP-HPLC Method Development and Validation for Simultaneous Estimation of Atzanavir and Ritonavir in Pharmaceutical Dosage Forms

Dr. Gampa Vijay Kumar1, B. Sravanthi2, K. Indhumathy3
1Professor and Head, Department of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
2KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
3KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.

A new method was established for simultaneous estimation of Atazanavir and Ritonavir by RP-HPLC method.  The chromatographic conditions were successfully developed for the separation of Atazanavir and Ritonavir  by using Agilent C18 5µm (4.6*250mm) column, flow rate was 1ml/min, mobile phase ratio was Methanol: ACN   (70:30%v/v), detection wave length was 238nm. The instrument used was HPLC Shimadzu Waters 996 LC 20 Software. The retention times were found to be 2.443 mins and 2.918 mins. The % purity of Atazanavir   and Ritonavir was found to be 100.7% and 101.4% respectively. The system suitability parameters for Atazanavir   and Ritonavir such as theoretical plates and tailing factor were found to be 1.7, 2114.5and 1.7, 2931.0 the resolution was found to be 8.0.The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study for Atazanavir   and Ritonavir 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% and 100.5%, %RSD for repeatability was 2.0 and 2.0, % RSD for intermediate precision was 1.5 and 1.1 respectively.  The precision study was precise, robust and repeatable. LOD value was 2.95 and 3.04, and LOQ value was 9.87 and 10 respectively. Hence the suggested RP-HPLC method can be used for routine analysis of Atazanavir   and Ritonavir  in API and Pharmaceutical dosage form.

Keywords: Agilent C18, Atazanavir   and Ritonavir, RP-HPLC method

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