Real-Time Analysis of Tenofovir Release Kinetics Using Quantitative Phosphorus (31P) Nuclear Magnetic Resonance Spectroscopy

Autor: Sudhaunshu S. Purohit, Vivek Agrahari, Nathan A. Oyler, Bi-Botti C. Youan, Jianing Meng
Rok vydání: 2017
Předmět:
Zdroj: Journal of Pharmaceutical Sciences. 106:3005-3015
ISSN: 0022-3549
DOI: 10.1016/j.xphs.2017.03.043
Popis: The dialysis method is classically used for drug separation before analysis, but, does not provide direct and real-time drug quantification and has limitations affecting the dialysis rate. In this study, a phosphorus nuclear magnetic resonance (31P-qNMR) method is developed for the real-time quantification of therapeutic molecules in vitro. The release kinetics of model drug tenofovir (TFV: anti-HIV microbicide) was analyzed in vaginal fluid simulant (VFS), semen fluid simulant (SFS), and human plasma (HP) from chitosan nanofibers (size ~100–200nm) using the NMR (direct) method and compared with dialysis/UV-Vis (indirect) method. The assay was linear in VFS/SFS (0.20–5.0mM), HP (0.30–5.0mM) and specific (no drug 31P-qNMR chemical shift (~15ppm) interference with formulation/media components). LOD values were 0.075/0.10/0.20mM, whereas, LOQ values were 0.20/0.20/0.30mM in VFS/SFS/HP, respectively. The method was robust, precise (%RSE
Databáze: OpenAIRE