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T. Aishwarya1, 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 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 2.443mins and 2.918mins. 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
