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A new rapid ultra‐performance liquid chromatography method for the pharmacokinetic and bioavailability study of diclofenac sodium aqueous injection and lipid microsphere injection in rats
Author(s) -
Cui Yue,
Lin Xia,
Guan TingTing,
Zhang Yu,
Tang Xing
Publication year - 2010
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.1306
Subject(s) - chemistry , chromatography , diclofenac sodium , pharmacokinetics , high performance liquid chromatography , bioavailability , aqueous solution , detection limit , extraction (chemistry) , electrospray ionization , bioequivalence , selected reaction monitoring , mass spectrometry , tandem mass spectrometry , pharmacology , medicine
A novel, rapid and selective ultra performance liquid chromatography mass spectrometric method had been developed for the pharmacokinetic study of diclofenac sodium (DS) after single intravenous injection of DS aqueous injection and DS lipid microsphere (LM) injection in rats. Ketoprofen (KP) was used as internal standard. Samples were treated by a one‐step liquid liquid extraction. Separation was performed on an Acquity UPLC™ BEH C 18 column (50 × 2.1 mm i.d., 1.7 μm). The mobile phase consisted of acetonitrile–0.1% ammonium hydroxide aqueous solution (20 : 80, v/v) initially in the gradient mode. The detection was carried out by means of electrospray ionization mass spectrometry in negative ion mode with multiple‐reaction monitoring mode. Standard curves showed good linearity ( r > 0.99) from the plasma concentration of 0.1–50 μg/mL. The lower limit of quantification was 0.1 μg/mL. The intra‐ and inter‐day precisions and the accuracy all satisfied the acceptance criteria. The developed method was validated and successfully applied to the pharmacokinetics study of DS aqueous injection and LM injection. The results showed that the two preparations were bioequivalent in rats. Copyright © 2009 John Wiley & Sons, Ltd.