[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 x 250 mm, 5 microm), 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 degrees C. The limits bf detection were 0.1-3 mg/L. The linear regression equation for each component was obtained, and the correlation coefficients (r2) were better than 0.9981. 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.