中国临床药理学与治疗学2012，Vol.17Issue(10)：1157-1162,6.
高效液相色谱串联质谱法测定人血浆中吲达帕胺浓度及生物等效性研究
Determination of Indapamide in human plasma by liquid chromatography tandem mass spectrum and study on its bioequivalence
景贤 1王医成 1欧阳冬生 1陈尧 1周淦 1阳国平 2周宏灏 1谭志荣1
作者信息
- 1. 中南大学临床药理研究所,长沙410078,湖南
- 2. 中南大学湘雅三医院,长沙410013,湖南
- 折叠
摘要
Abstract
AIM: To establish a simple, effective and sensitive LC-MS/MS assay to determine Indapamide in human plasma. METHODS: Dia-zepam was used as an internal standard. Human plasma samples were extracted by MTBECtert-Butyl Methyl Ether). The separation was carried out on a Luna C18 (150 mm × 2. 0 mm, 5 μm) column. The mobile phase consisted of 10 mmol/ L ammonium formate with 0.1% formic acid: methanol (20 : 80, V/V) at a flow rate of 0. 30 mL/min. Electrospray ionization ( ESI) source was applied and operated in the positive ion mode. The MS detection parameters were as follows: the source voltage was 3. 5 KV and source temperature was 100 ℃. Quantitation was performed using multiple reaction monitoring (MRM) of the m/z 366. 2→132. 1 for Indapamide and 285. 2 → 154. 1 for diazepam. RESULTS:
The liner calibration curves were obtained in the range of 0. 536 - 45. 733 ng/mL for Indapamide. The lower limit of quantification was 0. 536 ng/ mL. The mean relative recovery was 69%～81% and the relative standard deviation of the intra-day and inter-day precision of variation were less than 15%. By single and multiple doses studies, we can demonstrate that Indapamide sustained release tablets (1. 5 mg/tablet) produced by Hunan Xieli Pharmaceutical Co. , Ltd and Servier (Tianjin) Pharmaceutical Co. ,Ltd are bioequiv-alent. CONCLUSION: This method which is simple and sensitive can be used to determinate the concentration of Indapamide in human plasma.关键词
LC-MS/MS/吲达帕胺/药物动力学/生物等效性Key words
LC-MS/MS/ Indapamide/ Phar-macokinetics/ Bioequivalence分类
医药卫生引用本文复制引用
景贤,王医成,欧阳冬生,陈尧,周淦,阳国平,周宏灏,谭志荣..高效液相色谱串联质谱法测定人血浆中吲达帕胺浓度及生物等效性研究[J].中国临床药理学与治疗学,2012,17(10):1157-1162,6.
