目的：建立高效液相法测定二甲双胍格列吡嗪片中盐酸二甲双胍含量测定方法。方法采用 C18（4.6 mm ×150 mm，5μm）色谱柱；以0.05%庚烷磺酸钠溶液（用10%磷酸溶液调节 pH 值至4.0）-乙腈（84：16）为流动相，流速：1.0 mL·min -1，检测波长：233 nm，柱温：30℃。结果盐酸二甲双胍在10.02~30.06μg·mL -1浓度范围内与峰面积呈良好的线性关系（r ＝0.9999），回收率为101.0%，RSD ＝0.66%（n ＝9）。结论所建立的方法较原国家注册标准专属性更强、更准确。%Objective To establish an HPLC method for the determination of metformin hydrochloride in Metformin and Glipizide Tablets. Methods The separation was performed on C18 column(4. 6 mm × 150 mm,5 μm),and the mobile phase was composed of 0. 05% sodium heptane - 1 - sulphonate solution(with 10% phosphoric acid solution to adjust pH value to 4. 0)- acetonitrile(84:16)with the flow rate of 1. 0 mL·min - 1 . The detection wavelength was 233 nm. The col-umn temperature was 30 ℃ . Results The linear range of metformin hydrochloride was 10. 02 ~ 30. 06 μg·mL - 1(r =0. 999 9). The average recovery rate was 101. 0% with RSD of 0. 66%(n = 9). Conclusion The established method was better and more accurate than the original national registered standard specificity.
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