Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Lamivudine, Tenofovir Alafenamide and Dolutegravir Bulk and their Combined Dosage Form

Abstract

Introduction: A simple and Rapid High Performance Liquid Chromatographic method was developed and validated for simultaneous estimation of lamivudine, tenofovir alafenamide and dolutegravir in their tablet dosage form. Method: The method was established using Agilent C18 (250 × 4.6 mm, i.d., 5 μm) column, a mobile phase consisting of 0.05M phosphate buffer pH 6.2 (solvent A) and acetonitrile (solvent B) 60:40 v/v at a flow rate of 1 mL/min with isocratic elution, injecting 10 µL sample into the chromatographic system. The eluted compounds were detected by using PDA Detector at a detection wavelength of 260 nm and the temperature was maintained at 30°C. Result: Retention times for the three compounds were found to be 3.09 min, 6.19 min and 9.61min for lamivudine, tenofovir alafenamide, and dolutegravir respectively. The linearity range was 10-80 µg/ml for three drugs with values of LOD found to be 0.56, 0.39µg, 1.35µg and LOQ were found to be 1.50µg, 0.99µg and 3.61 µg for lamivudine, tenofovir alafenamide and dolutegravir respectively which were linear enough showing correlation coefficient 0.999 in all the cases. Conclusion: The proposed method is therefore, suitable for the purpose in quality-control laboratories for quantitative analysis of the drugs individually and in the combined dosage form. The method was found to be as it is simple and rapid with tremendous precision and accuracy. The method can be used as a routine quality control method for triple combined dosage forms.

An effective stability indicating RP-HPLC method for simultaneous estimation of Dolutegravir and Lamivudine in bulk and their tablet dosage form

“…Extensive literature search revealed that few analytical methods such as UV methods and RP-HPLC methods were reported for estimation of Lamivudine and Dolutegravir individually [7][8][9][10][11]. Further, there are some RP-HPLC methods available for simultaneous estimation of Lamivudine, Dolutegravir, and tinofivir disproxil fumarate or butcaver sulfate or abacavir in triple combination [6,[12][13][14][15]. As per FDA official news, Lamivudine and Dolutegravir fixed dose film-coated tablet got an approval in April 2019 for the treatment of HIV-1.…”

A Novel UPLC-PDA Stability Indicating Method Development and Validation for the Simultaneous Estimation of Lamivudine and Dolutegravir in Bulk and Its Tablets

“…[6][7][8][9][10]. Additionally, few Rp-HPLC methods have been reported for the simultaneous estimation of LAM and DOL and tinofivir disporxil fumarate or butcaver sulfate and abacavir in triple combination [11][12][13][14][15]. The fixed dose film-coated tablets LAM and DOL approved by the USFDA in April 2019.…”

Stability Indicating RP-UPLC Method for Simultaneous Estimation of Emtricitabine, Tenofovirand Bictegravirin Bulk and Pharmaceutical Dosage Form

“…The literature survey reveals that few analytical methods were available for the estimation of Emtricitabine, Bictegravir and Tenofoviralafenamide in pharmaceutical dosage forms. The early reported methods available for the estimation of Emtricitabine and Tenofoviralafenamide are RP-HPLC [5][6][7][8][9] reverse phase high performance liquid chromatography method [TenofovirDisoproxilFumarate and Emtricitabine RPHPLC [9][10][11] reverse phase high performance liquidchromatography Method], Application of UV Spectrophotometric Methods for Simultaneous Estimation of Emtricitabine and TenofovirAlafenamideFumarate in Bulk 12 , spectrofluorimetric analysis 13 , reverse phase high performance liquid chromatography [14][15][16][17] . Since there are no official reported methods on Ultra-Performance Liquid Chromatographic (UPLC) methods for the simultaneous estimation of Emtricitabine, Bictegravir and Tenofoviralafenamide in the public domain and proposed method was cost effective and due to this,we have planned to develop a simple, precise, economic and accurate stability indicating Ultra-Performance Liquid Chromatographic (UPLC) method development and validation for the estimation of Emtricitabine, Bictegravir and Tenofoviralafenamide in pharmaceutical dosage form.…”