高效液相色谱法测定降糖中成药中添加的高极性化学降糖药物

建立了测定添加在降糖中成药中高极性的盐酸二甲双胍、盐酸苯乙双胍、阿卡波糖、伏格列波糖等4种化学降糖药物的高效液相色谱方法。采用Thermo氨基色谱柱(4.6 mm×250 mm,5 μm)分离,流动相组成为磷酸盐缓冲溶液(0.06%磷酸二氢钾和0.028%磷酸氢二钠溶液)-乙腈(体积比为30∶70)，流速为1 mL/min,紫外检测波长为195 nm,柱温为30 ℃,进样量为20 μL。结果表明,4种化学降糖药能完全分离,中成药基质不干扰测定；检出限为0.1～3 mg/L;4种药物具有宽的线性范围和良好的线性关系(r2≥0.9981);日内、日间测定的相对标准偏差(RSD)分别为0.10%～5.07%和0.19%～6.41%;在中成药中的加标回收率除了添加低浓度的伏格列波糖的回收率较低外，均高于80%,RSD为1.14%～4.82%。该方法用于中成药中高极性的化学降糖药的检测具有特异、快速、简便、高效的特点。

Simultaneous determination of four highly polar anti-diabetic drugs in Chinese traditional patent medicines using high performance liquid chromatography

A high performance liquid chromatographic (HPLC) method was established for the simultaneous determination of four highly polar anti-diabetic drugs, metformin hydrochloride, phenformin hydrochloride, acarbose, and voglibose, in Chinese traditional patent medicines. The separation was performed on a Thermo NH2 analytical column (4.6 mm×250 mm, 5 μm), the mobile phase consisted of 30%A and 70%B, where A included 0.06% potassium dihydrogen phosphate and 0.028% disodium hydrogen phosphate, B was acetonitrile. The flow rate was 1 mL/min, the detection wavelength was set at 195 nm, and the column temperature was 30 ℃. The limits of detection were 0.1-3 mg/L. The linear regression equation for each component was obtained, and the correlation coefficients （r2） were better than0.9981. The intra-day and inter-day relative standard deviations (RDSs) were 0.10%-5.07% and 0.19%-6.41%, respectively. The average recoveries of four anti-diabetic drugs spiked in blank Chinese traditional patent medicine matrixes were more than 80% except that for the low concentration of voglibose was 64.05%. The RSDs of the recoveries were 1.14%-4.82%. The method can be used in the analysis of the four highly polar anti-diabetic drugs in Chinese traditional patent medicines, and it is rapid, convenient, economic and specific.