Stability Indicating RP-UPLC Method for Assay of Emtricitabine and Tenofovir Disoproxil Fumarate in Bulk and Dosage Forms

Abstract

A simple, sensitive and rapid stability indicating reverse phase ultra performance liquid chromatography (RP-UPLC) method was developed and validated for the determination of Emtricitabine (EMT) and Tenofovir disoproxil fumarate (TDF) in pure and tablet dosage forms. The chromatographic separation was achieved by using Waters (Alliance) UPLC system equipped with auto-sampler and photo diode array detector. A volume of 5 μL of standard or test was injected into the column and the components were separated by using the mixture of 0.68% potassium dihydrogen orthophosphate buffer of pH = 6 and methanol in the ratio 45:55 v/v as mobile phase at a flow rate of 1.2 mL/min through BEH C18 (100 mm × 2.1, 1.8 μm) at ambient temperature and were detected at a wavelength of 261 nm. System suitable parameters such as plate count and tailing factor for EMT and TDF were found to be 2427 & 3685, 1.16 & 1.23 respectively, and resolution between EMT and TDF peaks was found to be 3.12. The chromatographic parameters like retention time, peak area and peak height of EMT and TDF were found to be 0.684 & 0.930, 694,200 & 8,778,000 and 272,881 & 3685 respectively. Percent of assay of EMT and TDF in bulk and dosage forms was determined and found to be 101.48 and 103.22 respectively. Study of degradation was examined and found that the drugs were stable under degradation conditions. The present method was developed keeping the principles of green chemistry by using eco-friendly solvent methanol in mobile phase. The developed method was found to be simple, rapid and applied for the analysis of Truvada; therefore the proposed method is recommended for the analysis of EMT and TDF in pure and tablet dosage forms in any quality control laboratories.