High-performance liquid chromatographic method for the determination of nelfinavir, a novel HIV-1 protease inhibitor, in human plasma

摘要: Nelfinavir mesylate, a potent and orally bioavailable inhibitor of HIV-1 protease (Ki=2 nM), has undergone Phase III clinical evaluation in large population HIV-positive patients. A high-performance liquid chromatography analytical method was developed to determine the pharmacokinetic parameters free base, nelfinavir, these human subjects. The involved extraction nelfinavir an internal standard, 6,7-dimethyl-2,3-di-(2-pyridyl)quinoxaline, from 250 microl plasma with mixture ethyl acetate-acetonitrile (90:10, v/v). analysis via ultraviolet detection at 220 nm using reversed-phase C18 column mobile phase consisting 25 mM monobasic sodium phosphate buffer (adjusted pH 3.4 phosphoric acid)-acetonitrile (58:42, v/v) that resolved drug standard peaks non-specific substances plasma. validated under Good Laboratory Practice (GLP) conditions for specificity, inter- intra-assay precision accuracy, absolute recovery stability. mean ranged 92.4 83.0% 95.7% standard. linear over concentration range 0.0300 microg/ml 10 microg/ml, minimum quantifiable level 0.0500 nelfinavir.