VALIDATED RP-HPLC METHOD FOR THE ASSAY OF TENOFOVIR DISOPROXIL FUMARATE AND EMTRICITABINE IN TABLETS AND BULK DRUG
Dr. J. N. Suresh Kumar*, Dr. B. Satya Prasad, R. Rajeswari
ABSTRACT
The pharmaceutical combined dosage forms of Emtricitabine and Tenofovir disoproxil fumarate are used for the treatment to help stop the spread of HIV in your body. A reverse-phase high-performance liquid chromatography method has been developed for simultaneous estimation of Emtricitabine and Tenofovir disoproxil fumarate available in combined tablet dosage form. The method was developed using Discovery 150x4.6mm, 5μ, and mobile phase composition of potassium dihydrogen phosphate Buffer: Acetonitrile (60:40A). The flow rate was adjusted at 1 ml/min for isocratic elution and detection was performed at 280 nm with UV detector. The retention time for Tenofovir disoproxil fumarate and Emtricitabine was found to be 3.039 min and 2.185 min, respectively. The method was validated as per ICH guidelines. The linearity range was found to be 3.75 to 22.5 μg/ml for Tenofovir disoproxil fumarate and 2.5 to 15 μg/ml for Emtricitabine. The percent recovery was found to 99.68 % for Tenofovir disoproxil fumarate, and 99.61 % for Emtricitabine, which indicate that method is accurate. The %RSD was found to be less than 2%, which indicates the developed method is precise. The proposed methods were successfully applied for the quantification of Tenofovir disoproxil fumarate and Emtricitabine in pharmaceutical formulations without any interference from excipients.
Keywords: Tenofovir Disoproxil fumarate (TDF), Emtricitabine, RP-HPLC, Robustness and Accuracy.
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