Abstract
BackgroundTo establish a simple, sensitive, accurate, precise, efficient, economical RP-UPLC method for simultaneous estimation of Doravirine, Lamivudine and Tenofovir disoproxil fumarate in bulk and their combined pharmaceutical formulations. Optimization of Chromatographic separation was achieved on analytical column HSS C18 (100 × 2.1 mm, 1.8 μ) maintained at temperature 30 °C and mobile phase consisting of 0.01 N Potassium dihydrogen orthophosphate buffer (pH-4.8) and acetonitrile in the ratio 60:40 v/v and at a flow rate 0.3 mL/min in isocratic mode. The injection volume was set as 1 µl detection wavelength is 260 nm. The proposed method validation was done as per International Council on Harmonization Q2 (R1) guidelines.ResultsDoravirine, Lamivudine and Tenofovir disoproxil fumarate were eluted at retention times of 1.2, 1.5, and 1.8 min respectively. The proposed method was identified an excellent linearity over concentration range of 12.5–75.0 µg/mL for Doravirine and 37.5–225.0 µg/mL for Lamivudine and 37.5–225.0 µg/mL for Tenofovir disoproxil fumarate. The percentage relative standard deviation for intra-day and inter-day precision of the present method was less than 2% for Doravirine, Lamivudine and Tenofovir disoproxil fumarate. Accuracy of the present method was evaluated by recovery studies which were in the range of 99.62–99.88% for Doravirine and 98.78–99.44% for Lamivudine and 99.67–100.52% for Tenofovir disoproxil fumarate. The limit of detection and limit of quantification were found to be 0.249 µg/mL and 0.756 µg/mL for Doravirine and 0.24 µg/mL and 0.727 µg/mL for Lamivudine and 0.797 µg/mL and 2.966 µg/mL for Tenofovir disoproxil fumarate. Forced degradation studies were carried out under various stress conditions like acid, base, peroxide, thermal, photo and neutral conditions.ConclusionsThe present method makes sure about no degraded impurity peak interference at the retention time of analyte peak hence can be applied for quality control investigation of Doravirine, Lamivudine and Tenofovir disoproxil fumarate in bulk and pharmaceutical formulations.
Highlights
To establish a simple, sensitive, accurate, precise, efficient, economical RP-UPLC method for simultaneous estimation of Doravirine, Lamivudine and Tenofovir disoproxil fumarate in bulk and their combined pharmaceutical formulations
DOR and LAM, Tenofovir disproxil fumarate (TDF) were successfully separated with fine resolution at retention time of 1.2 min, 1.5 min and 1.8 min respectively (Fig. 2) by using HSS (C18 100 × 2.1 mm, 1.8μ), mobile phase composition of buffer and Acetonitrile in 60:40 v/v at a flow rate of 0.3 mL/min and a wavelength of 260 nm was selected to detect three different analytes (Table 1)
In the reported HPLC methods, DOR and TDF were eluted at longer retention time and these methods were not considered as economical methods because of low sensitivity and more mobile phase consumption [27, 28]
Summary
Sensitive, accurate, precise, efficient, economical RP-UPLC method for simultaneous estimation of Doravirine, Lamivudine and Tenofovir disoproxil fumarate in bulk and their combined pharmaceutical formulations. Doravirine (DOR) is a synthetic derivative of pyridinone moiety significantly hinders the function of the non-nucleoside reverse transcriptase which is responsible for integration and replication of genome of the Human immune virus [1,2,3]. Triphosphate of LMV (3TCTP) is the competitive inhibitor of nucleoside reverse transcriptase [4,5,6]. Tenofovir is the active moiety of TDF ceases the replication of viral genome by inhibiting the nucleoside reverse transcriptase competitively [7,8,9]. DELSTRIGOTM is a recently approved combined tablet dosage form comprising three active moieties including Doravirine (DOR), Lamivudine (LAM) and Tenofovir disproxil fumarate (TDF).
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