Selective RP-HPLC DAD method for determination of tenofovir fumarate and emtricitabine in bulk powder and in tablets

Abstract

Summary.A simple and selective liquid chromatographic method was developed for the simultaneous determination of tenofovir disoproxil fumarate (TEN) and emtricitabine (EMT) in combined tablets. The method is based on separation of TEN and EMT on a Zorbax SB-C8 column, 5 μm, 4.6 × 250 mm, with a mobile phase consisting of 50 mM disodium hydrogen phosphate-acetonitrile (50:50, v/v). The mobile phase contains 0.1% triethylamine (TEA) and was adjusted to pH 6.0. Quantification of the analytes is achieved with diode array -ultraviolet detector (DAD-UV) at 260 and 280 nm for TEN and EMT, respectively, based on peak area. Different variables affecting the method were carefully investigated and optimized. Reliability and analytical performance of the proposed method, including linearity, range, precision, accuracy, and detection and quantitation limits, were statistically validated. The high-performance liquid chromatography (HPLC) method was successfully applied for determination of each drug in their binary tablets.

A green approach for the analysis of emtricitabine bictegravir and tenofovir in a pharmaceutical preparation using novel HPLC and spectrophotometric methods

“…TNF was quantified from various active ingredients using HPLC, LC–tandem mass spectrometry (LC–MS/MS; Gollu & Gummadi, 2020; Heydarzadeh et al, 2019; Olejarz et al, 2020; Paritala et al, 2021; Patel et al, 2019; Pavani & Susithra, 2022; Thakare et al, 2023; Xiao et al, 2020; Zhao et al, 2019), spectrophotometry (Buridi, 2013; Ghorpade et al, 2010; Karunakaran et al, 2011), spectrofluorimetry (Tiris et al, 2020), and electrochemical technique (Festinger et al, 2022; Xiao et al, 2022). EMC was analyzed by several techniques, including HPLC (Abdelhay et al, 2015; Haq et al, 2022; Runja et al, 2016), capillary electrophoresis (Guichard et al, 2021), and spectrophotometry (Abdelhay et al, 2013; Ashour & Belal, 2017). BIC was quantified from human plasma using LC–MS/MS (Schauer et al, 2022).…”

“…EMC was analyzed by several techniques, including HPLC (Abdelhay et al, 2015;Haq et al, 2022;Runja et al, 2016), capillary electrophoresis (Guichard et al, 2021), and spectrophotometry (Abdelhay et al, 2013;Ashour & Belal, 2017). BIC was quantified from human plasma using LC-MS/MS (Schauer et al, 2022).…”

Application of QBD Life Cycle Approach for Stability Indicating HPLC Method Development and Validation for the Estimation of Impurities in Tenofovir Disoproxil Fumarate and Emtricitabine Combination Tablets

“…The literature search revealed that there are number of analytical methods have been reported for single molecule or simultaneous estimation of TDF and FTC by HPLC [5][6][7][8][9][10][11][12] , by UPLC [13][14][15][16] , by mass spectroscopy 17 . Till date no stability indicating HPLC method has been reported for simultaneous estimation of related substances of TDF and FTC by QbD life cycle approach.…”