Abstract
Article history: Received on: 11/01/2016 Revised on: 09/02/2016 Accepted on: 04/03/2016 Available online: 30/03/2016 An accurate and precise UPLC method was developed for the simultaneous estimation of efavirenz and lamivudine in pharmaceutical dosage forms. The chromatographic analysis was performed on Acquity UPLC BEH Shield RP18 (50 × 3 mm, 1.7 µm) column with mobile phase consisting of 10% acetonitrile in methanol and 10 mM phosphate buffer (pH 4.0) in the gradient mode, at a flow rate of 0.4 mL/min, and eluents monitored at 254 nm. The calibration curves of peak area versus concentration, which was linear from 10-60 µg/mL for efavirenz and 5.0-30 µg/mL for lamivudine, had regression coefficient (r 2 ) greater than 0.999. The method had the requisite accuracy, precision, and robustness for simultaneous determination of efavirenz and lamivudine in tablets. The proposed method is simple, economical, accurate, and precise and could be successfully employed in routine quality control for the simultaneous analysis of efavirenz and lamivudine in pharmaceutical formulations.
Highlights
An accurate and precise UPLC method was developed for the simultaneous estimation of efavirenz and lamivudine in pharmaceutical dosage forms
Nucleoside reverse transcriptase inhibitors (NRTIs) were the first class of drugs that were introduced as antiretroviral agents for the treatment of infection with human immune deficiency virus (HIV)
The method was selective for the determination of EFV and 3TC since no interfering peaks appeared near the retention time of the compound of interest
Summary
Nucleoside reverse transcriptase inhibitors (NRTIs) were the first class of drugs that were introduced as antiretroviral agents for the treatment of infection with human immune deficiency virus (HIV). They are protease inhibitors (PIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), fusion inhibitors (Farmer et al, 2001). Chemically (4S)-6-chloro-4-(2cyclopropylethynyl)-4-(trifluoromethyl)-2, 4-dihydro-1H-3, 1benzoxazin-2-one, is a non-nucleoside reverse transcriptase inhibitor. It is used in the treatment of HIV infection (Figure 1). Lamivudine, chemically 4-amino-1-{(2R, 5S)-2-(hydroxyl methyl)-1, 3-oxathiolan-5-yl}-1, 2-dihydropyrimidin-2-one, is a nucleoside reverse transcriptase inhibitors with activity against. Present study involves development and validation of UPLC method for the simultaneous estimation of efavirenz and lamivudine in combined tablet dosage form, which is fast, sensitive with better resolution and peak symmetry. The developed method was validated to assess the validity of research data means determining whether the method used during the study can be trusted to provide a genuine, account of the intervention being evaluated
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