糖尿病患者尿液中常见药物含量的高效液相色谱法测定

Simultaneous Determination of Three Diabetic Drugs in Urine by High Performance Liquid Chromatography

建立了高效液相色谱／二极管阵列检测法同时测定糖尿病患者尿液中二甲双胍、格列吡嗪和替米沙坦3种常用药物含量的方法。室温条件下以2．5mmol／L十二烷基硫酸钠－20mmol／L磷酸二氢钠（pH4．6）－乙腈为流动相，梯度洗脱，实现了3种药物的有效分离。采用3种不同检测波长，测得二甲双胍、格列吡嗪和替米沙坦的检出限分别为13．6（λ=232nm）、31．5（λ=276nm）、57．0μg/L（λ=297nm），对应的线性范围分别为1．0～100．0、1．0～100．0、5．0—250．0mg／L，回收率为82％～113％，相对标准偏差（RSD）为1．5％～3．1％。利用该法对9名糖尿病患者尿样中的3种药物残留量进行分析，结果表明该方法样品处理简便，色谱分离完伞．结果准确可靠．为糖尿病患者尿液中的药物代谢鲴学研穷提供了基础．

A high performance liquid chromatographic （HPLC） method was established for the simultaneous determination of 3 drugs for diabetic mellitus （DM）, including metformin hydrochloride, glipizide and telmisartan, in urine. The macromolecules in urine samples of DM patients were firstly removed by acetone precipitation method, and the supernatants were dried and redissolved in methanol. Then the extracts were analyzed by HPLC coupled with a diode-array detector. The separation of analytes was performed on an Inertsil ODS column by gradient elution using acetonitrile -2.5 mmol/L SDS -20 mmol/L NaH2PO4 solution （pH = 4. 6） as mobile phase. The recoveries of 3 diabetic mellitus drugs were in the range of 82% - 113% with relative standard deviations of 1.5% -3.1% . To obtain highest sensitivity, different wavelengths were chose for different drugs. The detection limits were 13.6 μg/L for metformin hydrochloride at 232 nm, 31.5 μg/L for glipizide at 276 nm and 57.0 μg/L for telmisartan at 297 nm, respectively. The linear ranges of metformin hydrochloride, glipizide and telmisartan were in the range of 1.0 - 100.0, 1.0 - 100. 0, 5.0 -250.0 mg/L, respectively. The method was used to detect the contents of 3 drugs in real urine samples of DM patients. The result showed the method was applicable for the study of DM pharmaco metabonomics.