The present work was aimed at the development of an analytical method with high sensitivity, selectivity, and rapidity for pharmacokinetic studies. The new method for quantitative determination of fludrocortisone in human blood plasma employs HPLC and mass spectrometric detection with electrospray ionization (ESI). The deuterium-labeled analog of fludrocortisone (fludrocortisone-D5) was used as the internal standard. The lower limit of quantitation (LLOQ) was 10 pg/mL. The calibration curve was linear in the range 10 – 1000 pg/mL. The coefficient of reliability was at least 0.99. Liquid extraction was used for sample preparation. The proposed technique was tested by studying the bioequivalence of a generic drug in a single administration to healthy volunteers at a dose of 0.1 mg.

目前的工作旨在开发一种用于药代动力学研究的具有高灵敏度、选择性和快速性的分析方法。定量测定人血浆中氟氢可的松的新方法采用 HPLC 和电喷雾电离 (ESI) 质谱检测。氘标记的氟氢可的松类似物（氟氢可的松-D5）用作内标。定量下限 (LLOQ) 为 10 pg/mL。校准曲线在 10 – 1000 pg/mL 范围内呈线性。信度系数至少为 0.99。液体萃取用于样品制备。所提议的技术通过研究以 0.1 毫克剂量向健康志愿者单次给药的仿制药的生物等效性进行了测试。