SIMULTANIOUS DETERMINATION OF ANTIRETROVIRAL DRUGS EMTRICITABINE AND TENOFOVIR DESOPROXIL FUMERATE BY A STABILITY INDICATING RP-HPLC METHOD
Objective: The objective of the present investigation is to develop a stability indicating RP-HPLC method for the simultaneous estimation of Emtricitabine (EMT) and Tenofovir Desoproxil Fumerate (TDF) in pure and tablet dosage forms.
Methods: Waters (Alliance) HPLC 2695 series systems equipped with UV detector was adopted for the chromatographic analysis. The separation was achieved by injecting 20 Âµl of working standard solution of concentration 60 Âµg/ml of EMT and 90 Âµg/ml of TDF into the Inertsil ODS C-18 (250 mm x 4.6 mm, 5 Âµm) column maintained at ambient temperature, elution was carried out by 0.1% triflouro acetic acid (TFA) buffer and methanol in the ratio 39:61 (v/v) as mobile phase at a flow rate of 1.2 ml/min, and the detection at a wavelength at 261 nm.
Results: The system suitability parameters such as tailing factor (1.41&1.43), theoretical plates (2470&3059), resolution (4.21) and chromatographic parameters like retention time (2.387&3.293 min), peak area (147228&250057), peak height (20731&26892) of EMT and TDF were evaluated. The developed method was validated in terms precision (for system precision and method precision, the %RSD was found to be 0.4637&0.3176 and 0.3502&0.2789 for EMT and TDF respectively), accuracy (percent of recovery was found to be 99.21-100.16&100.78-101.16), linearity (20-100Âµg/ml&30-150 Âµg/ml), limit of detection (0.48&0.56 Âµg/ml), limit of quantitation (1.64&1.89 Âµg/ml) for EMT and TDF respectively. The developed method was applied for the determination of assay of Truvada and the percent of assay was found to be in the range of 100.74-101.56.
Conclusion: A simple, rapid and economic RP-HPLC method for simultaneous determination of EMT and TDF in bulk and formulations was developed and validated. The developed method was found to be precise, accurate, linear, robust and rugged. This method was successfully applied for the assay of Truvada; hence it can be adopted for the determination of quality in any quality control laboratory.
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