A Validated Chiral LC-MS/MS Method for the Enantioselective Determination of (S)-(+)- and (R)-(-)-Ibuprofen in Dog Plasma: Its Application to a Pharmacokinetic Study

被引:7
作者
Choi, Sanghee [1 ,2 ]
Shim, Wang-Seob [2 ]
Yoon, Jiyoung [1 ,2 ]
Choi, Doowon [1 ,2 ]
Lee, Jinseong [3 ]
Paik, Soo-Heui [4 ]
Chung, Eun-Kyoung [5 ]
Lee, Kyung-Tae [1 ,2 ,6 ]
机构
[1] Kyung Hee Univ, Grad Sch, Dept Biomed & Pharmaceut Sci, Seoul 02447, South Korea
[2] Kyung Hee Univ, Coll Pharm, Kyung Hee Drug Anal Ctr, Seoul 02447, South Korea
[3] BNC KOREA Inc, Dept BD&RA Div, Seoul 06296, South Korea
[4] Sunchon Natl Univ, Coll Pharm, Sunchon 57922, South Korea
[5] Kyung Hee Univ, Coll Pharm, Dept Pharm, Seoul 02447, South Korea
[6] Kyung Hee Univ, Coll Pharm, Dept Pharmaceut Biochem, Seoul 02447, South Korea
关键词
ibuprofen; dexibuprofen; enantiomer; LC-MS/mS; beagle dog plasma; validation; bioanalytical method validation; pharmacokinetics; PERFORMANCE LIQUID-CHROMATOGRAPHY; IBUPROFEN ENANTIOMERS; STEREOSELECTIVE METABOLISM; INCURRED SAMPLE; INVERSION; S(+)-IBUPROFEN; DEXIBUPROFEN; BIOINVERSION; INFUSION; STANDARD;
D O I
10.3390/pharmaceutics15030824
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
The purpose of this study was to develop a method for simultaneously separating ibuprofen enantiomers using electrospray ionization (ESI) liquid chromatography with tandem mass spectrometry (LC-MS/MS). LC-MS/MS was operated with negative ionization and multiple reaction monitoring modes; transitions were monitored at m/z of 205.1 > 160.9 for ibuprofen enantiomers, 208.1 > 163.9 for (S)-(+)-ibuprofen-d3 [internal standard 1 (IS1)], and 253.1 > 208.9 for (S)-(+)-ketoprofen (IS2), respectively. In a one-step liquid-liquid extraction, 10 mu L plasma was extracted with ethyl acetate:methyl tertiary-butyl ether of 7:3. Enantiomer chromatographic separation was carried out with an isocratic mobile phase consisting of 0.008% formic acid in water-methanol (nu/nu) at a flow rate of 0.4 mL/min on a CHIRALCEL (R) OJ-3R column (150 x 4.6 mm, 3 mu m). This method was fully validated for each enantiomer and results were in compliance with the regulatory guidelines of the U.S. Food and Drug Administration and the Korea Ministry of Food and Drug Safety. The validated assay was executed for nonclinical pharmacokinetic studies after oral and intravenous administration of racemic ibuprofen and dexibuprofen in beagle dogs.
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页数:17
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