金鑫鹿成韬冯彦来丁莉坤关月孙薇周伦文爱东.LC-MS/MS 法测定人血浆中伊伐布雷定浓度及药动学[J].,2011,11(14):2605-2608 |
LC-MS/MS 法测定人血浆中伊伐布雷定浓度及药动学 |
Determination of Ivabradine in Human Plasma by LC-MS/MS and Studyof Pharmacokinetics |
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DOI: |
中文关键词: 伊伐布雷定 药代动力学 液相色谱- 质谱- 质谱 |
英文关键词: Ivabradine Pharmacokinetics LC-MS/MS |
基金项目:国家科技重大专项课题(2008ZX09312-024) |
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中文摘要: |
目的:建立人血浆中伊伐布雷定的液相色谱- 质谱- 质谱联用测定方法,研究健康人体药代动力学。方法:以地西泮为内标
物,采用液相色谱- 质谱- 质谱联用法,电喷雾电离源选择性正离子峰检测。测30 名健康志愿者单剂量口服盐酸伊伐布雷定片的
体内血药浓度,获得药动学参数。结果:伊伐布雷定在0.101-101 ng·mL-1 浓度范围内呈良好的线性关系(r=0.998),最低检测浓度
为0.101 ng·mL-1。高、中、低浓度的方法提取回收率分别为93.2 %、86.6 %、87.5 %,日内、日间精密度RSD 均小于15 %。结论:
LC-MS/MS 方法灵敏度高,专属性强,准确,简便,适用于盐酸伊伐布雷定片的人体药代动力学研究。 |
英文摘要: |
Objective: To determine ivabradine in human plasma by a LC/MS/MS method, and to investigate its pharmacokinetics.
Methods: Ivabradine concentrations in plasma were determined by LC-MS/MS. The test and reference formulations of ivabradine were
given to 30 healthy male volunteers. Results: The linear range for rosuvastatin was 0.101-101 ng·mL-1(r = 0.998). The quantitation limit
for rosuvastatin was 0.101 ng·mL-1. The draw recovery rates were 93.2 %, 86.6 % and 87.5 %, and RSD for intra-day and inter-day was
both less than 15 %. Conclusion: LC-MS/MS method is sensitive, accurate and simple, and suitable for the study on pharmacokinetic of
ivabradine in human. |
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