SIMULTANEOUS ESTIMATION OF LAMIVUDINE, ABACAVIR AND DOLUTEGRAVIR BY UPLC METHOD

Somshankar Dubey,Mahesh Duggirala

doi:10.22159/ijap.2018v10i1.21156

Abstract

Objective: To develop a simple, rapid, sensitive and effective reverse phase ultra-performance liquid chromatographic method (RP-UPLC) for simultaneous quantification of lamivudine, abacavir and dolutegravir in pure and tablet dosage forms.Methods: Chromatographic separation was performed by using Waters-ACQUITY UPLC system equipped with auto sampler, photodiode array (PDA) detector, zodiac sil RP C18 (4.6 mm × 250 mm, 3.0 µm) column, phosphate buffer (pH 3.0) and methanol in the ratio of 30:70 %v/v have been delivered at a flow rate of 0.25 ml/min and the detection was carried out using a Ultraviolet (UV) detector at a wavelength of 260 nm at ambient column temperature. The mobile phase was used as diluent.Results: The retention time (Rt) for lamivudine, abacavir and dolutegravir were 1.763, 2.247 and 3.175 min respectively. A good linear response was obtained in the range of 15-75 µg/ml, 30-150 µg/ml and 2.5-12.5 µg/ml, respectively. The Limit of Detection (LOD) values were found to be 0.021, 0.330 and 0.038 µg/ml, respectively and the Limit of Quantitation (LOQ) values were 0.056, 1.320 and 0.095 µg/ml, respectively.Conclusion: It was concluded that the developed RP-UPLC method was effective, suitable and conducive for analyzing lamivudine, abacavir and dolutegravir in pharmaceutical formulations. The method was quantitatively evaluated in terms of precision, linearity, accuracy (recovery), selectivity and robustness in accordance with standard guidelines.

Highlights

Antiretroviral therapy (ART) has evolved significantly over the last three decades since the development of the first nucleoside analogues NRTIs
In August 2013, Dolutegravir was approved by Food and Drug Administration (FDA) for its use in both patients who have never taken ART (ART-naïve) and patients who have taken ART (ART-experienced) [3-5]
Waters-ACQUITY UPLC consisted of binary solvent manager with part number: 186015001, sample manager with part number: 186015005, single column manager with part number: 186015007 and photodiode array (PDA) detector with part number: 186015026 with Waters Empower 2 PC workstation used for method development and validation

Summary

Introduction

Antiretroviral therapy (ART) has evolved significantly over the last three decades since the development of the first nucleoside analogues NRTIs (nucleoside reverse transcriptase inhibitors). The major limiting factors for improving the long-term success of ART are tolerability and convenient pill burden [2]. The latest class of the antiretroviral drugs developed was integrase inhibitors (INI). 1) is an integrase inhibitor, focused on maintaining a favorable safety profile and a highefficiency rate within a single-tablet regimen (STR). It improves resistance barrier and allowing co-formulation with an NRTI backbone. Dolutegravir has been compared against both other classes of Human Immunodeficiency Virus (HIV) antiretrovirals as well as other integrase nuclear strand inhibitors. It is predicted that very soon an STR containing dolutegravir, abacavir and lamivudine will become available

Methods

Results

Conclusion