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建立了适用于测定人血浆中厄贝沙坦和氢氯噻嗪浓度的液相色谱-质谱(LC-MS)法,并将其应用于厄贝沙坦氢氯噻嗪人体药代动力学研究。人血浆样品采用液-液萃取法提取,内标为对乙酰氨基酚。采用依利特C_(18)柱,以乙腈-水(35:65,v/v)为流动相,选择离子监测负离子模式检测,厄贝沙坦m/z为427.25,氢氯噻嗪m/z为295.95,内标对乙酰氨基酚m/z为150.05。厄贝沙坦和氢氯噻嗪的日内和日间精密度(RSD%)均低于14.5%,准确度(RE%)分别低于1.9%和-2.0%。厄贝沙坦在10-5000ng/mL浓度范围内线性关系良好(r>0.99),氢氯噻嗪在1-200ng/mL浓度范围内线性关系良好(r>0.99)。所建立的方法已成功应用于厄贝沙坦氢氯噻嗪人体药代动力学研究。
A liquid chromatography-mass spectrometry (LC-MS) method for the determination of irbesartan and hydrochlorothiazide in human plasma was established and applied to the human pharmacokinetics study of irbesartan hydrochlorothiazide. Human plasma samples were extracted by liquid-liquid extraction and the internal standard was paracetamol. Ion-exchange ionization was used to detect negative ions with Elisartan C 18 column with acetonitrile-water (35:65, v / v) as mobile phase. The m / z of irbesartan was 427.25 and the m / z of hydrochlorothiazide was 295.95. Internal standard acetaminophen m / z was 150.05. The intra- and inter-day precision (RSD%) of irbesartan and hydrochlorothiazide were both below 14.5% and the accuracy (RE%) was below 1.9% and -2.0%, respectively. Irbesartan had a good linear relationship (r> 0.99) at a concentration range of 10-5000 ng / mL and a good linearity (r> 0.99) over a concentration range of 1-200 ng / mL. The established method has been successfully applied to irbesartan hydrochlorothiazide human pharmacokinetic study.