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目的用高效液相色谱法测定二甲双胍格列本脲片(Ⅰ)中盐酸二甲双胍的含量。方法采用依利特C18色谱柱(4.6 mm×250 mm,5μm),流动相为0.01 mol.L-1磷酸二氢钾溶液(用磷酸调pH至3.0)-甲醇(35∶65),流速为1.0 mL.min-1,柱温为室温,检测波长为233 nm。结果盐酸二甲双胍浓度在5.95～119μg.mL-1范围内线性关系良好,r=0.999 8;平均回收率为99.48%,RSD=0.6%(n=6)。结论该法简便、快速、准确、专属性强,可作为二甲双胍格列本脲片(Ⅰ)中盐酸二甲双胍的含量测定。
Objective To determine the content of metformin hydrochloride in metformin glibenclamide tablets (Ⅰ) by high performance liquid chromatography. Methods Elite C18 column (4.6 mm × 250 mm, 5 μm) was used. The mobile phase consisted of 0.01 mol·L-1 potassium dihydrogen phosphate solution (adjusted to pH 3.0 with phosphoric acid) -methanol (35:65) at a flow rate of 1.0 mL.min-1, the column temperature was room temperature, the detection wavelength was 233 nm. Results The concentration of metformin hydrochloride was good in the range of 5.95-119 μg · mL-1, r = 0.999 8. The average recovery was 99.48% and the RSD was 0.6% (n = 6). Conclusion The method is simple, rapid, accurate and specific, and can be used as the content of metformin hydrochloride in metformin glibenclamide tablet (Ⅰ).