Stability indicating UPLC method to quantify Emtricitabine, Tenofovir, and Efavirenz simultaneously in tablets: Method establishment

Abstract

An easy, precise, specific, and accurate UPLC method for the quantification of emtricitabine (ETC), tenofovir (TFR), and efavirenz (EVR) in their tablet dosage form was developed and validated. ETC, TFR, and EVR were separated and estimated using Waters UPLC with HSS C18 (100 × 3 mm, 1.7 μ) column. The mobile phase was 0.01 N potassium dihydrogen phosphate buffer (pH 4.5) and acetonitrile (40:60, vol/vol). The elution of ETC, TFR, and EVR was achieved using flow rate at 0.4 ml/min and detected at 265 nm using a photodiode array detector. The detector response was linear from 75 to 450 μg/ml for TNF, 50 to 300 μg/ml for ETC, and 150 to 900 μg/ml for EVR. The limit of detection and limit of quantification were 0.601 µg/ml and 1.82 µg/ml, 0.330 µg/ml and 0.100 µg/ml, 0.911 µg/ml and 2.76 µg/ml for TNF, ETC and EVR respectively. Validation was carried out in compliance with ICH guidelines. It was noticed that all validation parameters were inside the permissible range.