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目的建立同时测定复方盐酸二甲双胍片中格列美脲和盐酸二甲双胍含量的方法。方法采用RP-HPLC法。色谱柱为Diamonsil C18柱(150 mm×4.6 mm,5μm),流动相为乙腈-20 mmol.L-1磷酸氢二钠溶液(含8 mmol.L-1十二烷基硫酸钠,磷酸调pH值7.5)(体积比为33∶67),流速为1 mL.min-1,检测波长为228 nm。结果格列美脲和盐酸二甲双胍的线性范围分别为0.1～0.6 mg.L-1(r=0.999 1,n=6)和25.0～150.0 mg.L-1(r=0.999 6,n=6);平均回收率分别为99.4%(RSD=1.0%,n=9)和99.8%(RSD=0.39%,n=9)。结论本方法简便、准确,可用于复方盐酸二甲双胍片的质量控制。
Objective To establish a method for the simultaneous determination of glimepiride and metformin hydrochloride in compound metformin hydrochloride tablets. Methods RP-HPLC method. The column was a Diamonsil C18 column (150 mm × 4.6 mm, 5 μm) with a mobile phase of acetonitrile-20 mmol·L -1 disodium hydrogen phosphate solution (containing 8 mmol·L -1 sodium dodecyl sulfate, pH adjusted with phosphoric acid Value of 7.5) (volume ratio of 33:67) at a flow rate of 1 mL.min-1 with a detection wavelength of 228 nm. Results The linear range of glimepiride and metformin hydrochloride was 0.1-0.6 mg.L-1 (r = 0.999 1, n = 6) and 25.0-150.0 mg.L-1 (r = 0.999 6, n = 6) The average recoveries were 99.4% (RSD = 1.0%, n = 9) and 99.8% (RSD = 0.39%, n = 9), respectively. Conclusion The method is simple and accurate and can be used for the quality control of compound metformin hydrochloride tablets.