科研之友
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摘要
A simplified, highly selective and sensitive method for the simultaneous quantitation of clevidipine and its primary metabolite H152/81 in beagle dog whole blood with liquid chromatography-tandem mass spectrometry (LC-MS/MS) was presented in this study. The chromatographic separation was performed on a Hedera ODS-2 column under a gradient elution. The quantitative analysis was operated in positive electrospray ionization (ESI) mode by multiple reaction monitoring (MRM) transitions. It was a critical challenge to deal with the stability issues which was mainly attributed to an ester linkage in the structure of clevidipine, thus a series of strategies have been utilized to overcome the intractable problem. The LC-MS/MS method obtained satisfactory validation results with the desired linearity, precision, accuracy, extraction recovery, matrix effect and stability, which was then successfully applied in a randomized, two-period, two-way cross-over, single-dose preclinical bioequivalence assay of two different clevidipine formulations in beagles.
