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