ABSTRACT

The main aspiration of this research work is to assess and validate the Lamivudine, tenofovir disoproxil fumarate and efavirenz in bulk and marketed formulation. The exploration was carried out by using Hypersil BDS column, (150×4.6mm, particle size 5?) and PDA detector at 258nm. The mobile phase containing Methanol:0.1%TFA: acetonitrile(30:40:30v/v) in isocratic mode pumped into a column at a flow rate 0.8mL/min. The method was validated according to ICH Q2(R1) guidelines. The linearity was perceived in the range of 10-50?g/mL for lamivudine, tenofovir disoproxil fumarate and 20-100?g/mL for efavirenz. The method was accurate with % recovery of 100.41%, 99.69% and 99.75% for Lamivudine, Tenofovir disoproxil fumarate and Efavirenz respectively. The percentage relative standard deviation was NMT 2, indicating that it was precise and robust. Under stress instances, execution of forced degradation studies such as acidic (0.1N HCL), Basic (0.1N NaOH), oxidative (3%H2O2), Photolytic (95%RH) and thermal (800C). The extent of degradation was accomplished within the acceptable limits i.e., 5-20%. The acquired method was precise, accurate and can be utilized for the estimation of lamivudine, tenofovir disoproxil fumarate and efavirenz in bulk and tablet dosage form. Keywords: Lamivudine, Tenofovir disoproxil fumarate, Efavirenz, HPLC, Forced degradation studies
Publication date: 01/09/2023

https://ijbpas.com/pdf/2023/September/MS_IJBPAS_2023_7394.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.9.7394