A New Validated Stability Indicating RP-HPLC Method for the Simultaneous Estimation of Emtricitabine and Tenofovir Disoproxil Fumarate in Bulk Drug and Pharmaceutical Dosage Form

M. Bharathi*, P. Rameeja, V. Haribaskar, Ramesh Dhani, B. Swathi
Department of Pharmaceutical Analysis, Ratnam Institute of Pharmacy, Pidathapolur, Muthukur, Nellore– 524 346

A B S T R A C T
Simple precise and accurate method was developed for the estimation of Emtricitabine and Tenofovir disoproxil. The mobile phase consisting 80% buffer 20% Acetonitrile. The column was used Inertsil ODS (4.6 x 250mm, 5m) with flow rate 1ml/min using PDA detection at 260 nm. The estimation of Emtricitabine and Tenofovir disoproxil was done by RP-HPLC. The assay of Emtricitabine and Tenofovir DF was performed with tablets and the % assay was found to be 100.64 and 99.97 which shows that the method is useful for routine analysis. The linearity of Emtricitabine and Tenofovir DF was found to be linear with a correlation coefficient of 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 0.8 and 0.4 for Emtricitabine and Tenofovir DF 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 0.7 and 0.1 for Emtricitabine and Tenofovir DF 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 99.96% and 99.86% for Emtricitabine and Tenofovir DF. 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 3.02 and 10.00 and LOD and LOQ for Tenofovir DF was found to be 3.00 and 9.98.The robustness limit for mobile phase variation and flow rate variation are well within the limit, which shows that the method is having good system suitability and precision under given set of conditions.
Keywords: Emtricitabine, Tenofovir disoproxil, RP-HPLC