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目的:建立高效液相色谱法测定消糖灵胶囊中格列本脲的含量。方法:以十八烷基硅烷键合硅胶为填充剂;以甲醇-磷酸二氢铵溶液(取磷酸二氢铵1.725g,加水300mL溶解,用磷酸调节pH值至3.5±0.05)(65∶35)为流动相;检测波长为230nm。进样量:20μL;理论板数按格列本脲峰计算应不低于5000。结果格列本脲质量浓度线性范围是7.8~62.4μg/mL,R=0.9999;平均加样回收率为99.85%,RSD为1.73%(n=9)。结论:HPLC法可控制消糖灵胶囊中格列本脲的含量,准确度高,重现性好,方法简便。
Objective: To establish a method for the determination of glibenclamide in Xiaoshiling Capsules by high performance liquid chromatography. Methods: The octadecylsilane bonded silica gel was used as a filler. A methanol-ammonium dihydrogen phosphate solution (1.725g of ammonium dihydrogen phosphate, dissolved in 300mL of water and adjusted to pH 3.5 ± 0.05 with phosphoric acid) (65:35 ) As mobile phase; detection wavelength of 230nm. Injection volume: 20μL; the number of theoretical plates calculated by the glyburide peak should be not less than 5000. Results The linear range of glyburide concentration was 7.8 ~ 62.4μg / mL, R = 0.9999. The average recovery was 99.85% with RSD of 1.73% (n = 9). Conclusion: HPLC method can control the content of glibenclamide in Xiaoshiling Capsules with high accuracy, good reproducibility and simple and convenient method.