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建立人血浆中孟鲁司特的LC-ESI-MS测定方法。孟鲁司特钠血浆样品用乙腈沉淀蛋白后,经Ci 8柱分离,流动相为20mmol/L醋酸铵缓冲盐溶液(包含0.2%甲酸)一甲醇(12:88,v/v)。LC-ESI-MS测定法采用选择性离子监测模式(SIM),检测离子为孟鲁司特的[M+H]~+m/z 586.2和内标替米沙坦的[M+H]~+离子m/z 515.2,线性范围是1ng/mL-1000ng/mL,最低定量限为1ng/mL,方法的批内和批间相对标准偏差(精密度)分别小于5.9%和10.0%。此方法已成功地用于孟鲁司特钠片剂在中国健康受试者体内的药动学研究。
LC-ESI-MS method for the determination of montelukast in human plasma. The montelukast sodium plasma samples were precipitated with acetonitrile and separated on Ci8 column using a mobile phase of 20 mmol / L ammonium acetate buffered saline (containing 0.2% formic acid) -methanol (12:88, v / v). LC-ESI-MS was performed on a selective ion monitoring mode (SIM) with [M + H] ~ + m / z 586.2 with montelukast and [M + H] ~ + Ion m / z 515.2 with a linear range of 1 ng / mL to 1000 ng / mL and a minimum limit of quantification of 1 ng / mL. The relative standard deviation (precision) of the method was less than 5.9% and 10.0%, respectively. This method has been successfully used to study the pharmacokinetics of montelukast sodium tablets in healthy Chinese subjects.