HPLC法检测降糖中药制剂中非法添加的格列本脲

目的建立降糖中药制剂中所添加的格列本脲的定性、定量检测方法。方法采用高效液相色谱法。色谱柱:C18柱(4.6 mm×250 mm,5μm);流动相:0.1 mol·L-1磷酸二氢钾-乙腈(53∶47);流速1.0 mL·min-1;柱温35℃;检测波长300 nm。结果 1种供试品中检出格列本脲。格列本脲浓度在0.051～1.014 4 mg·mL-1范围内,峰面积与进样量呈良好的线性关系,相关系数r=1.000,平均回收率为99.97%,RSD为1.3%。结论本方法简便易行、准确可靠,可作为监测降糖中药制剂非法添加格列本脲的有效方法。

Detection of glibenclamide illegally mixed into traditional Chinese antidiabetic preparations by HPLC

Objective To establish a qualitative and quantitative detection method for glibenclamide in traditional Chinese antidiabetic preparations. Methods HPLC was adopted on a C18chromatographic column （4.6 mm × 250 mm ,5μm）. The mo- bile phrase was 0.1 mol . L-1 potassium dihydrogen phosphate -acetonitrile（53：47） at flow rate of 1.0 mL. min-1 ,the column temperature was 35 ℃ and the detection wavelength was 300 nm. Results One traditional Chinese medicine contained glib- euclamide. Glibenclamide showed good linear relationship within the range of 0.051 - 1. 014 4 mg . mL^-1 （ r = 1. 000）. The aver- age recovery was 99.97% with the RSD of 1.3%. Conclusion The method was simple, accurate and reliable, and it can be used for the detection of glibenclamide illegally mixed into traditional Chinese antidiabetic preparations.