Abstract
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE USING REVERSE PHASE HPLC METHOD IN BULK AND TABLET DOSAGE FORM

Shaik Uzma Nousheen* and Dr. M. Srinivas

ABSTRACT

Objective: A New method was established for simultaneous estimation of Emtricitabine and Tenofovir disoproxil fumarate by RP-HPLC method. Methods: The chromatographic conditions had been effectively advanced for the separation of Emtricitabine and tenofovir by way of using Edurasil ODS-3 C18(4.6 x 50mm, 3.5m) column, go with the flow charge changed into 1ml/min, cellular segment ratio become Phosphate buffer (0.05M) pH four.6: ACN (30: 70) (pH become adjusted with orthophosphoric acid), detection wave period was 250nm. The device used turned into WATERS HPLC Auto Sampler, Separation module 2695, PDA Detector 996, Empower-software model-2. Results: Retention time of Emtricitabine and tenofovir were found to be 0.919 min and 1.732 min. The % purity of Emtricitabine and tenofovir was found to be 99.7 % and 99.04 % respectively. The system suitability parameters for Emtricitabine and tenofovir such as theoretical plates and tailing factor were found to be 1.56, 2744.20 and 1.19, 33.75.11. The linearity study for Emtricitabine and tenofovir was found in concentration range of 20μg-100μg and 30μg-150μg and correlation coefficient (r2) was found to be 0.999 and 0.999 % % RSD for intermediate precision was 0.6 and 0.69 respectively. The precision study was precise, robust and repeatable. LOD value was 2.98 and 2.96, and LOQ value was 9.98 and 9.96 respectively. Conclusion: The results of study showed that the proposed RP‐HPLC method is a simple, accurate, precise, rugged, robust, fast and reproducible, which may be useful for the routine estimation of Emtricitabine and Tenofovir disoproxil fumarate in pharmaceutical dosage form.

Keywords: Emtricitabine, Tenofovir disoproxil fumarate. RP?HPLC.


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