Abstract
An accurate and precise RP-HPLC method was developed and for the simultaneous determination of Emtricitabine and Tenofovir in Pharmaceutical dosage form and was validated as per ICH guidelines. The separation was achieved on an Inertsil ODS Column (250 x 4.6 mm, 5 micron) as a stationary phase and Methanol: Water (80:20) v/v as mobile phase, with at a flow rate of 1 ml/min and separation was monitored by UV detector, at a detection wavelength of 260 nm. Retention time of Emtricitabine and Tenofovir was obtained at 2.893 and 3.932 min. respectively. Validation was performed as per ICH guidelines which include accuracy, precision, linearity, specificity, ruggedness and robustness. The linearity was found to lie between 20-100 µg/ml for Emtricitabine and 30-150 µg/ml for Tenofovir disoproxil fumarate. The Percentage recovery of Emtricitabine and Tenofovir was found to lie in the range of 98.0 – 102.0 %. Hence the proposed method was found to be fast, precise and accurate, since the run time is less than 5 minutes and the mobile phase preparation does not require an elaborative procedure. Hence the proposed method can be applied for the routine quality control of pharmaceutical preparations in combined dosage form.
