离子对高效液相色谱法测定人血清中盐酸二甲双胍浓度  

Ion Pair - HPLC Determination of Metformin Hydrochloride Concentration in Human Serum

作　　者：赵春丽[1] 刘建芳[1] 胡玉钦[1] 曹丽霞[1] 刘会臣[1] 

机构地区：[1]白求恩国际和平医院临床药理室,石家庄050082

出　　处：《药物分析杂志》2004年第5期471-473,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立测定人血清中盐酸二甲双胍浓度的反相离子对高效液相色谱法。方法:血清样品用乙腈沉淀蛋白后离心,上清液直接进样。使用Diamonsil C18(150 mm×4.6 mm,5μm)分析柱,流动相为0.01 mol·L-1磷酸二氢钠缓冲液(pH 4.5,含辛烷基磺酸钠5 mmol·L-1)-乙腈(50:8),流速1 mL·min～2,紫外检测波长240 nm,外标法峰高定量。结果:盐酸二甲双胍浓度在0.06—4.0μg·mL-1范围内与峰高线性关系良好,线性范围内高、中、低3个浓度的方法回收率在95.6%-104.6%,日内RSD<3.0%,日间RSD<6.0%。结论:本法简便、灵敏、准确,适用于二甲双胍血药浓度检测及药动学研究。Objective:To develop a ion pair - HPLC method for the determination of metformin hydrochloride in human serum. Methods:The serum protein was precipitated by acetonitrile and the resulting supernatant after centrifuge was directly injected onto the HPLC system. The separation was performed on a Diamonsil C18 (150 mm× 4. 6 mm,5 μm)analytical column,with the mixture of 0. 01 mol · L-1 phosphate buffer(pH 4. 5 ,containing sodium octylsulfonate 5 mmol · L -1 ) and acetonitrile ( 50: 8 ) as the mobile phase at 1. 0 mL · min -1. The UV detection wavelength was 240 nm. Peak height was used for quantification in external standard method. Results:A good linearity was obtained from 0. 06 to 4. 0 μg · mL -1 serum concentration of metformin hydrochloride. The recoveries were between 95. 6% and 104. 6%. Intra - day and inter - day RSD were less than 3. 0% and 6. 0% respectively. Conclusion ; The method is simple, sensitive and accurate, it can be used for the blood drug concentration monitoring and clinical pharmacokinetic study of metformin.

关 键 词：盐酸二甲双胍 人血清 RSD 药动学研究 离子对高效液相色谱法 血药浓度 反相离子 血清样品 紫外检测波长 磷酸二氢钠 

分 类 号：R446[医药卫生—诊断学] R977.15[医药卫生—临床医学]