Development of a Stability Indicating UPLC-MS/MS Method for Rapid and Reliable Determination of Fenofibrate in Marketed Product (Lypanthyl 200M) and Human Plasma

Abstract

A reliable, fast, sensitive and selective Ultra Performance Liquid Chromatography-Tandem Mass Spectrometry (UPLC-MS/MS) method has been developed and validated for the determination of fenofibrate in marketed product (Lipanthyl) and human plasma. The chromatographic separation was performed on a reversed-phase Acquity®BEH C18 column (1.7 μm particle size, 50 mm x 2.1 mm ID) with an isocratic elution profile and mobile phase consisting of methanol and water (80:20, %, v/v). To achieve optimum chromatographic condition the influence of mobile phase composition and flow rate was investigated. The total chromatographic analysis time was as short as 2 min. Detection and quantification of the analyzed drug sample were carried out with a triple quadrupole mass spectrometer using Electrospray Ionization (ESI) operating in positive ionization mode. The data acquisition was performed in Multiple Reactions Monitoring (MRM) mode. The method was validated over a concentration range of 0.5-200ng/mL (r2=0.993, n=6). The selectivity, matrix effect, recovery, accuracy, precision, and stabilities were validated for determination of fenofibrate in human plasma. Analytical recoveries of extracted fenofibrate from plasma were more than 92%. The validation results showed that the proposed method was sensitive, economical and less toxic and it could successfully be applied for evaluation of pharmacokinetics of fenofibrate in animals.