Abstract
BackgroundAn easy, defined, rapid, and accurate reverse phase high-performance liquid chromatography method was developed and subsequently validated for the concurrent estimation of lamivudine, efavirenz, and tenofovir disoproxil fumarate in their pure blend and combined tablet formulation. An efficient and appropriate separation of the three analytes was attained with Zorbax eclipse XDB-Phenyl column, with a mobile phase of methanol: buffer (0.1% v/v formic acid in water) (73:27 v/v) at a flow rate of 1mL/min and isocratic elution by using 260nm as detection wavelength. Equal ratio of acetonitrile and water was used as diluent.ResultsThe retention times of lamivudine, tenofovir disoproxil fumarate, and efavirenz were found at 2.6, 4.4, and 5.9 min respectively. The linear response for lamivudine, tenofovir disoproxil fumarate, and efavirenz was in the range of 15.0–45.0μg/mL, 15.0–45.0μg/mL, and 20.0–60.0 μg/mL respectively. The method validation was done in accordance to ICH guidelines and all validation parameters in compliance with ICH standards. The degradants produced by stress testing were well resolved from the peaks of active analytes, which stipulates the stability-indicating property of the method.ConclusionThe method has the ability to separate lamivudine, efavirenz, and tenofovir disoproxil fumarate concurrently in blended powder and their combined tablet. All degradants produced by application of stress conditions were separated with high resolution and determined with good sensitivity that ensures the stability-indicating property of the method. Thus, the projected method has high probability to adopt in the pharmaceutical industrial sector.
Highlights
An easy, defined, rapid, and accurate reverse phase high-performance liquid chromatography method was developed and subsequently validated for the concurrent estimation of lamivudine, efavirenz, and tenofovir disoproxil fumarate in their pure blend and combined tablet formulation
The three-drug combination of lamivudine (LAM), tinofovir disproxil fumarate (TDF), and efavirez (EVZ) is a competent highly active anti-retroviral therapy which comprise of one non-nucleoside reverse transcriptase inhibitor and two nucleoside reverse transcriptase inhibitor drugs [1, 2]
It was observed that LAM and TDF were freely soluble in water and acetonitrile and slightly soluble in methanol, and EVZ was soluble in methanol and acetonitrile and insoluble in water
Summary
An easy, defined, rapid, and accurate reverse phase high-performance liquid chromatography method was developed and subsequently validated for the concurrent estimation of lamivudine, efavirenz, and tenofovir disoproxil fumarate in their pure blend and combined tablet formulation. Multi-drug combination therapy is compliance by the patients due to decreased pill load per day. The three-drug combination of lamivudine (LAM), tinofovir disproxil fumarate (TDF), and efavirez (EVZ) is a competent highly active anti-retroviral therapy which comprise of one non-nucleoside reverse transcriptase inhibitor and two nucleoside reverse transcriptase inhibitor drugs [1, 2]. LAM, chemically, is 4-amino-1[(2R, 5S)-2-(hydroxyl methyl)-1,3-oxathiolan-5-yl]-1, 2-dihydropyrimidin-2-one [3]. It ceases DNA replication by inhibiting the reverse transcriptase enzyme competitively [4]. TDF, chemically, is 1-(6-aminopurine -9-yl) propan-2 yl]
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.