摘要
目的:建立测定人血浆样品中盐酸二甲双胍浓度的定量分析方法。方法:反相高效液相色谱法(RP-HPLC法)。色谱柱为Nucleosil100-5硅胶柱(250mm×4.6mm,5μm),流动相为0.03mol/L的磷酸二氢铵溶液(pH=7.00)-乙腈(75∶25,V/V),检测波长240nm,柱温30℃,进样量40μL。结果:血浆中盐酸二甲双胍浓度线性范围是25～4000ng/mL(r=0.9999),回收率在94.59%～100.84%之间,日内RSD(n=5)在0.67%～2.35%之间,日间RSD(n=5)在2.77%～4.09%之间,最低检测限是12.5ng/mL。结论:HPLC法简便、快捷、灵敏、准确,适用于临床药代动力学及药效学的研究。
Objective： To establish HPLC method for assaying metformin hydrochloride in human plasma. Methods： Metformin hydrochloride in the samples were quantitatively analyzed by HPLC method without the internal standard. HPLC conditions for metformin hydrochloride were as follows： a chromatogram column with a Nucleosil 100-5 silica column （250 mm×4.6 mm,5μm）.The mobile phase consisted of 0.03 mol/L phosphate buffer（pH=7.0）-acetonitrile（75 ： 25） with a flow rate of 1.0 mL/min, and the detective wavelength was 240 nm. Results： The linear range was 25-2000 ng/mL of metformin hydrochloride concentration （r=0.9999）,recoveries of metformin hydrochloride from plasma were 94.59%-100.84%;the variation coefficients of intra-day（n=5） and inter-day（n=5） were 0.67%-2.35% and 2.77%-4.09%. And the minimal determinable concentration was about 12.5μg/mL in plasma. Conclusion： This method was simple, rapid, accurate, and suitable for being applied to study of pharmacokinetics and pharmacodynamics of metformin hydrochloride in clinic.
出处
《中国药业》
CAS
2005年第11期67-68,共2页
China Pharmaceuticals
