ABSTRACT

An economical, rapid, and precise stability-indicating UHPLC method for simultaneous quantification of HIV therapeutic agents (emtricitabine and tenofovir disoproxil fumarate) in pure standard and pharmaceutical matrices. The UHPLC separation analysis was achieved on UPLC BEH C18 (150 mm × 2.1 mm) with 1.7 µm particle size column at ambient temperature using a solvent system in a proportion of (70:30 % v/v) potassium dihydrogen orthophosphate buffer: methanol; pH 2.8 ± 0.03 was adjusted with 0.1 % OPA. The PDA detector has functioned as a mode for analysis for identification and confirmation of peak purity. In order to evaluate the assay procedure’s stabilityindicating efficacy, emtricitabine and tenofovir disoproxil fumarate were experienced to various stress procedures of forced degradation analysis like acidic, alkaline, and neutral hydrolysis, oxidative, photodegradation, and thermal degradation (dry and wet heat). The designed approach was successful in distinguishing the selected therapeutics from the peaks of their respective degradation products. Furthermore, the designed approach demonstrated calibration plots for emtricitabine and tenofovir disoproxil fumarate in over wide concentration ranges of 3 – 18 ?g/mL and 10 – 60 ?g/mL, respectively, with determination coefficients (r2) of 0.9983 and 0.9999. The method validation assays had relative standard deviations of less than 2 % for accuracy, precision (intra- and inter-day assay variance), repeatability, and robustness. Therefore, simultaneous quantification of both HIV therapeutic agents in tablet matrices was accomplished. Keywords: Emtricitabine; Forced degradation study; Stability-indicating assay; UHPLC method; Tenofovir disoproxil fumarate
Publication date: 25/01/2022

https://ijbpas.com/pdf/2022/January/MS_IJBPAS_2022_JAN_SPCL_2_2010.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.1.2010