A Validated Rp-Hplc Method For Simultaneous Determination Of Lamivudine, Tenofovir Disoproxil Fumarate And Efavirenz In Tablet Formulation

Abstract

A simple, rapid, specific, accurate, robust and reproducible Reverse phase HPLC method was developed and validated for the estimation of Emtrictabine, Tenofovir and Efavirenz in pure and pharmaceutical dosage forms. The quantification was carried out using Inertsil ODS-3V column C₁₈ (250×4.6mm, 5µm) with mobile phase composing of Acetonitrile: 1%IPA in 80:20%v/v at flow rate 1ml/min, detection was carried out at 256nm using PDA detector with injection volume 20µl, the retention time was found to be 2.4, 2.8 and 5.2. The proposed method was validated as per ICH Q2B guidelines. The method produced linear response in the concentration ranges of 5-25µg/ml (R²= 0.999), 7.5-37.5µg/ml (R²= 0.999) and 15-45µg/ml (R²= 0.999). The recovery studies were carried out and found to be within 98-102%. The %RSD was found to be within limit. LOD &LOQ of method was found to be within limit. The proposed method was statistically evaluated and can be applied for the routine analysis and quality control of raw materials, formulation for Emtricitabine, Tenofovir and Efavirenz.