摘要
目的建立了一种简便、快速的体外人血浆中盐酸二甲双胍的离子对高效液相色谱方法。方法盐酸二甲双胍血样以乙腈除蛋白,用C18反相柱,0.01mol·L-1NaH2PO4和0.0075mol·L-1十二烷基磺酸钠-乙腈(65∶35)为流动相;流速:1.0ml/min;苯妥英钠为内标;在235nm波长进行检测。结果该方法的线性关系良好(r=0.9993),线性范围为0.05～4μg·ml-1,检出限为0.010μg·ml-1。高、中、低3种浓度的日内、日间精密度、方法回收率和萃取回收率均符合方法学要求。结论该法简便,准确可靠,结果稳定,可用于盐酸二甲双胍的药代动力学研究和生物利用度研究。
Aim A simple and rapid reversed-phase high performance liquid chromatographic （Ion Pair-HPLC） method has been established for the determination of meffonnin hydrochloride in human plasma. Methods Plasma samples were pretreated by direct deproteinization with acetonitrile. The separation was performed on a C18 column with a mobile phase consisting of acetonitrile-0.01mol .L^-1 sodium dihydrogen phosphate and 0. 037 5mol·L^-1 sodium dodecyl sulphate. The UV-Vis detector was set at 235 nm and phenytoin sodium was used as the internal standard. Results The linear range of the method was between 0.05ug·ml^-1 and 41ug·ml^-1 with a correlation coefficient of 0.999 3 ,and the detection limit was 0.010ug·ml^-1. The intra-day and inter-day relative standard deviations for assaying the plasma samples containing three levels of metformin hydrochloride were 3.5% ,2. 8% ,2.9 % and 3.2% ,2.7% ,2.6% （ n =5）,respectively. The mean recovery was 101.1% and the mean extraction recovery was 90. 1%. Conclusion The reversed-phase high performance liquid chromatographic （ RP-HPLC ） method was simple, accurate, stable and suitable for studying the pharmacokinetics and relative bioavailability of metformin hydrochloride.
出处
《解放军药学学报》
CAS
2008年第6期534-537,共4页
Pharmaceutical Journal of Chinese People's Liberation Army
