Wednesday , 19 September 2018

Analytical Method Validation for Essay of Emitricitabine, Rilpevirene and Tenofovir Alfanamide by RP-HPLC

Vasini Revathi, M. Shymala*
Department of Analysis, Joginapally B.R. Pharmacy College, Yenkapally, Moinabad, Hyderabad, Telangana-500075

A B S T R A C T
A new, simple, precise, accurate and reproducible RP-HPLC method for Simultaneous estimation of Emtricitabine and Tenofovir and Rilpivirine in bulk and pharmaceutical formulations. Separation of Emtricitabine and Tenofovir and Rilpivirine was successfully achieved on a Inertsil ODS C18 (4.6 x 250mm, 5mm) utilizing Phosphate buffer pH 3: Acetonitrile (30:70) at a flow rate of 1.0 mL/min and elute was monitored at 280 nm, with a retention time of 4.4945 and 7.971 and10.513 minutes for Emtricitabine and Tenofovir and Rilpivirine. The assay of Emtricitabine, Tenofovir and Rilpivirine was performed with tablets and the % assay was found to be 99.69 and 100.31 and 99.50 which shows that the method is useful for routine analysis. The linearity of Emtricitabine, Tenofovir and Rilpivirine was found to be linear with a correlation coefficient of 0.999 and 0.999 and 0.999 which shows that the method is capable of producing good sensitivity. The acceptance criteria of precision is RSD should be not more than 2.0% and the method show precision 0.2 and 0.2 and 0.1 for Emtricitabine, Tenofovir and Rilpivirine which shows that the method is precise. The acceptance criteria of intermediate precision is RSD should be not more than 2.0% and the method show precision 0.1 and 0.3 and 0.3 for Emtricitabine, Tenofovir and Rilpivirine which shows that the method is repeatable when performed in different days also. The accuracy limit is the percentage recovery should be in the range of 97.0% – 103.0%. The total recovery was found to be 99.98% and 99.78% and 99.97 for Emtricitabine, Tenofovir and Rilpivirine. The validation of developed method shows that the accuracy is well within the limit, which shows that the method is capable of showing good accuracy and reproducibility.The acceptance criteria for LOD and LOQ is 3 and 10.The LOD and LOQ for Emtricitabine was found to be 2.98 and 9.98and LOD and LOQ for Tenofovir was found to be 3.00 and 10.00 and LOD and LOQ for Rilpivirine was found to be 2.94 and 9.97.

Keywords: Emtricitabine, Tenofovir, Rilpivirine, HPLC.

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