Concurrent estimation of lamivudine, tenofovir disoproxil fumarate, and efavirenz in blended mixture and triple combination tablet formulation by a new stability indicating RP-HPLC method

Abstract Background 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...

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Main Authors: Ramreddy Godela, Vijayalaxmi Kammari, Sowjanya Gummadi, Durgaprasad Beda
Format: Article
Language:English
Published: SpringerOpen 2021-04-01
Series:Future Journal of Pharmaceutical Sciences
Subjects:
Online Access:https://doi.org/10.1186/s43094-021-00249-9
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spelling doaj-1ed32321eefa4a5eb823c9b93a5d6c082021-05-02T11:44:15ZengSpringerOpenFuture Journal of Pharmaceutical Sciences2314-72532021-04-017111210.1186/s43094-021-00249-9Concurrent estimation of lamivudine, tenofovir disoproxil fumarate, and efavirenz in blended mixture and triple combination tablet formulation by a new stability indicating RP-HPLC methodRamreddy Godela0Vijayalaxmi Kammari1Sowjanya Gummadi2Durgaprasad Beda3Department of Pharmacy, GITAM Deemed to be UniversityDepartment of Pharmaceutical Analysis, MLR Institute of PharmacyDepartment of Pharmacy, GITAM Deemed to be UniversityDepartment of Pharmaceutical Analysis, Bhaskar Pharmacy CollegeAbstract Background 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. 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. Results The 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. Conclusion The 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.https://doi.org/10.1186/s43094-021-00249-9LamivudineEfavirenzTenofovir disoproxil fumarateStress testingStability indicatingIsocratic elution
collection DOAJ
language English
format Article
sources DOAJ
author Ramreddy Godela
Vijayalaxmi Kammari
Sowjanya Gummadi
Durgaprasad Beda
spellingShingle Ramreddy Godela
Vijayalaxmi Kammari
Sowjanya Gummadi
Durgaprasad Beda
Concurrent estimation of lamivudine, tenofovir disoproxil fumarate, and efavirenz in blended mixture and triple combination tablet formulation by a new stability indicating RP-HPLC method
Future Journal of Pharmaceutical Sciences
Lamivudine
Efavirenz
Tenofovir disoproxil fumarate
Stress testing
Stability indicating
Isocratic elution
author_facet Ramreddy Godela
Vijayalaxmi Kammari
Sowjanya Gummadi
Durgaprasad Beda
author_sort Ramreddy Godela
title Concurrent estimation of lamivudine, tenofovir disoproxil fumarate, and efavirenz in blended mixture and triple combination tablet formulation by a new stability indicating RP-HPLC method
title_short Concurrent estimation of lamivudine, tenofovir disoproxil fumarate, and efavirenz in blended mixture and triple combination tablet formulation by a new stability indicating RP-HPLC method
title_full Concurrent estimation of lamivudine, tenofovir disoproxil fumarate, and efavirenz in blended mixture and triple combination tablet formulation by a new stability indicating RP-HPLC method
title_fullStr Concurrent estimation of lamivudine, tenofovir disoproxil fumarate, and efavirenz in blended mixture and triple combination tablet formulation by a new stability indicating RP-HPLC method
title_full_unstemmed Concurrent estimation of lamivudine, tenofovir disoproxil fumarate, and efavirenz in blended mixture and triple combination tablet formulation by a new stability indicating RP-HPLC method
title_sort concurrent estimation of lamivudine, tenofovir disoproxil fumarate, and efavirenz in blended mixture and triple combination tablet formulation by a new stability indicating rp-hplc method
publisher SpringerOpen
series Future Journal of Pharmaceutical Sciences
issn 2314-7253
publishDate 2021-04-01
description Abstract Background 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. 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. Results The 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. Conclusion The 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.
topic Lamivudine
Efavirenz
Tenofovir disoproxil fumarate
Stress testing
Stability indicating
Isocratic elution
url https://doi.org/10.1186/s43094-021-00249-9
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