中国临床药理学与治疗学2012，Vol.17Issue(7)：785-790,6.
HPLC-MS-MS法测定人血浆中芬太尼浓度及其生物等效性研究
Determination of fentanyl in human plasma by HPLC-MS-MS and study on its bioequivalence
田莹莹 1王医成 1武惠斌 2邓晓兰 1谭志荣 1周宏灏 1欧阳冬生1
作者信息
- 1. 中南大学临床药理研究所,长沙410078,湖南
- 2. 河南羚锐制药股份有限公司,信阳465550,河南
- 折叠
摘要
Abstract
AIM: To establish an HPLC-MS/ MS assay to determine fentanyl in human plasma. METHODS; D-fentanyl was used as an in-teral standard. Human plasma samples were ex-
tracted by n-hexane. The separation was carried out on an Thermo Hypurity C18 (150 mm × 2. 1 mm, 5 μm) column at 40 C. The mobile phase consisted of methanol — 0. 1% formic acid (85 :
15, V/V) at a flow rate of 0. 3 mL/min. Elec-trospray ionization (ESI) source wa.s applied and operated in the positive ion mode. Quantitaion wa.s performed using multiple reaction monitoring (MRM) of the m/z 337. 1 → 188. 1 for fenta-nyl , and m/z 341. 9→187. 9 for D-fcntanyl. RESULTS; The liner calibration curves were obtained in the range of 19.53 — 5000 pg/mL for fentanyl. The lower limit of quantification was 19. 53 pg/mL. The relative standard deviation of the intra-assay and inter-assay precision of variation was less than 5. 16%. The extraction recovery for fentanyl was above 90%. To study the
pharmacokinetics of two transdermal patches of fentanyl, preparations were given to 24 healthy volunteers, and the relative bioavailabihty of AUC0-144 was (94.0+19.5)%. CONCLUSION: It is an accurate, sensitive and rapid method that can be applied to determine fentanyl in human plasma. Two preparations of fentanyl are bio-equivalent.关键词
芬太尼/液相色谱-质谱联用/生物等效性Key words
Fentanyl/ HPLC-MS/MS/ Bioequivalence分类
医药卫生引用本文复制引用
田莹莹,王医成,武惠斌,邓晓兰,谭志荣,周宏灏,欧阳冬生..HPLC-MS-MS法测定人血浆中芬太尼浓度及其生物等效性研究[J].中国临床药理学与治疗学,2012,17(7):785-790,6.
