Research Journal of Pharmacy and Technology
Year : 2022, Volume : 15, Issue : 5
First page : ( 1981) Last page : ( 1988)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.52711/0974-360X.2022.00329

New stability indicating RP-UFLC method for the quantification of Efavirenz in pharmaceutical dosage forms

Aluri Sai Gnaneswari, Annapurna Mukthinuthalapati Mathrusri^*

Department of Pharmaceutical Analysis, GITAM School of Pharmacy, Gandhi Institute of Technology and Management (Deemed to be University), Visakhapatnam, India

^*Corresponding Author E-mail: mmukthin@gitam.edu

Online published on 20 February, 2023.

Abstract

Efavirenz is an active non-nucleoside reverse transcriptase inhibitor used for the treatment of human immunodeficiency virus (HIV) type 1. A simple and validated new stability indicating RP-UFLC method has been developed for the estimation of Efavirenz in pharmaceutical dosage forms i. e. tablets. Shimadzu UFLC system (PDA detector) with Zorbox C₁₈ column was chosen for the chromatographic study with flow rate 1.2 mL/min (UV detection at 252 nm). Beer-Lambert’s law was obeyed over a concentration range 0.05-160 μg/mL. The linear regression equation was found to be y = 44317x + 8491.1 (R² = 0.9993). The LOD and LOQ was found to be 0.0142 and 0.0429 μg/mL respectively. Stress degradation studies were performed and the method was validated as per ICH guidelines. The proposed method is simple, precise, accurate and robust and can be applied for the quantification of Efavirenz formulations.

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Keywords

Efavirenz, RP-UFLC, Stability indicating, Validation, ICH guidelines.

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