ABSTRACT

A Stability-indicating reversed phase high liquid chromatography (RP-HPLC) was developed which can separate and accurately quantitate Emtricitabine, Bictegravir and Tenofovir alafenamide. This method was successfully validated for the purpose of conducting stability studies in Quality Control (QC) laboratories. The Chromatographic separation was achieved on Inertsil ODS C18 (4.6 x 250mm, 5?m) as stationary phase with a mobile phase comprising of Methanol, Acetonitrile and Phosphate buffer of pH 3 adjusted with 5 % Orthophosphoric Acid (30:30:40 V/V). The mobile phase was sonicated for 10 minutes and filtered through 0.45? membrane filter. The flow rate was 1 ml/min; column temperature of 40 ± 20 C and UV detection was performed at 260 nm. The retention times of Emtricitabine, Bictegravir and Tenofovir was found to be 1.125, 2.108 and 2.745 min respectively. The proposed RP-HPLC Method was validated and all the parameters are given for Method Validation. The method was quantitatively evaluated in terms of linearity, precision, accuracy, selectivity and robustness as per standard guidelines. The method is simple, convenient and suitable for the analysis of Emtricitabine, Bictegravir and Tenofovir alafenamide in bulk and pharmaceutical formulations. Keywords: Stability, RP-HPLC, Emtricitabine, Bictegravir, Tenofovir
Publication date: 01/05/2024

https://ijbpas.com/pdf/2024/May/MS_IJBPAS_2024_7989.pdf

Download PDF
https://doi.org/10.31032/IJBPAS/2024/13.5.7989