Abstract
Objective: In this study, a RP-HPLC (stability-indicating) based assay method for the estimation of doravirine (DRV), tenofovir disoproxil fumarate (TFF) and lamivudine (LMV) simultaneously in the tablets was described.
 Methods: The simultaneous analysis of DRV, TFF and LMV was done with HPLC system (Agilent 1100 series) and Luna Phenomenex C18 (250 mm × 4.6 mm × 5 μ) column with isocratic mobile phase (35% volume ratio of methanol and 65% volume ratio of 20 mmol ammonium formate, pH 5). Validation of assay method was done on sensitivity, linearity, accuracy, selectivity, precision, robustness and specificity.
 Results: The calibration curves were linear through the range of 25-200 µg/ml for DRV and 75-600 µg/ml for TFF and LMV. The percent relative standard deviation for intraday variation/precision, interday variation/precision, intermediate precision/ruggedness and robustness were lower than 2%. The recovery of LMV (99.09-99.76%), TFF (99.10-99.41%) and DRV (98.65-99.28%) confirmed the good accuracy. The stability of LMV, TFF and DRV in 0.1N NaOH, 3% peroxide, 0.1 N HCl, UV light and dry heat of 60 °C was determined.
 Conclusion: The results have allowed the method to be implemented in the tablets to quantify DRV, TFF, and LMV.
Highlights
The human immunodeficiency virus is categorized in the Lentivirus genus, Retroviridae family and Orthoretrovirinae subfamily [1]
The simultaneous analysis of DRV, tenofovir disoproxil fumarate (TFF) and LMV in the tablets and bulk materials was done with the HPLC system (Agilent 1100 series, G1311 A Quaternary pump, G1316 A thermostat column, G1329 A autosampler and programmable G1314 A UV detector) and Luna Phenomenex C18 (250 mm × 4.6 mm × 5 μ)
The quantitative approach developed for the combined assay of DRV, TFF and LMV in the tablets has been validated in accordance with the standards of the International Conference on Harmonization [29, 30]
Summary
The human immunodeficiency virus is categorized in the Lentivirus genus, Retroviridae family and Orthoretrovirinae subfamily [1]. The human immunodeficiency virus is categorized into two groups, HIV type 1 and HIV type 2, based on genetic features and variations in the viral antigens [2]. The assessed number of people active with HIV infection as of 2019 is 38 million [3, 4]. Among 38 million, 1.8 million were children below 15 y age and 36.2 million were adults. As of 2019 end, there had been global access to antiretroviral treatment for 25.4 million individuals with HIV infection. This means that still 12.6 million people are waiting
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