反相高效液相色谱法测定盐酸二甲双胍血浆药物浓度

Detection of Metformin Hydrochloride Concentration in Human Plasma by RP-HPLC Method

目的：采用反相高效液相方法测定血浆中盐酸二甲双胍的药物浓度。方法：色谱柱为KromasilC18OSD柱，流动相：水相（10mmol／L磷酸二氢钠含4mmol／L辛烷基磺酸钠）：乙腈=85：15，流速1．0ml／min，柱温25℃，灵敏度0．1AUFS，检测波长233nm。结果：盐酸二甲双胍在0．05～4．00μg／mL范围内线性关系艮好（y=1.1386e^6＋52879．8，r=0．9999，n=7），最低定量限：0．05μg／mL，低、中、高3种浓度水平日内和日间差异（RSD％）分别为1．32．1．14．0．29（n=5）及2．79、7．37、7．00（n=5）。相对回收率低、中、高分别为98．5％、100．8％、102．9％，平均回收率（100．7±2.20）％。结论：本方法处理过程简单，可快捷、准确的应用于盐酸二甲双胍的血浆浓度测定。

Objective： The RP-HPLC method was established to detect the concentration ofmetformin in human plasma.Methods： TheHPLC method was performed on KromasilC18 OSD column（250mm×4.6mm, 7 μm）,a mixture of 85% mmol/L NaH2PO4 which contained 4 mmol/L NaSO3C8H17 and 15 % acetonitrile as mobile phase. The flow rate was 1.0ml/min and the column temperature was 25℃, the detection wavelength was 233nm.Results： The linear ranges of metformin hydrochloride was 0.05 to 4 lag/mL（r=0.999 9）. The LLOQ was 0.05 μg/mL. The precision ofwithin-day（RSD %） and inter-day（RSD %） were 1.32, 1.14, 0.29 （n=5） and 2.79, 7.37, 7.00 （n=5）, the mean recovery was （100.74- 2.20）%.Conclusion： The method was simple, convenient and accurate, and can be used for detecting concentration of metformin in human olasma.