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目的:建立HPLC法消渴丸的快速鉴别方法和格列本脲的限量检查方法。方法:消渴丸的HPLC鉴别采用Hy-persil BDS C18色谱柱(4.6 mm×150 mm,5μm),乙睛:0.1%磷酸水溶液,非线性程序梯度洗脱,检测波长235 nm,理论塔板数大于3000;格列本脲的限量检查采用Hypersil ODS C18色谱柱(4.6 mm×200 mm,5μm),甲醇:磷酸二氢铵溶液洗脱,检测波长230 nm,理论塔板数大于6000。结果:在消渴丸的HPLC定性鉴别中,以五味子甲素、葛根素、格列本脲对照品作为定性指标,HPLC法能够区分出真伪消渴丸;格列本脲检测限为50.2 ng/ml。结论:表明方法简便易行,检测专属性强、重现性好,可以用于消渴丸的质量控制。
OBJECTIVE: To establish a rapid method for the determination of Xiaoke Pill by HPLC and the limited test method for glyburide. Methods: The HPLC method was used for the determination of Xiaoke Pills by Hy-persil BDS C18 column (4.6 mm × 150 mm, 5 μm), acetonitrile: 0.1% phosphoric acid aqueous solution and nonlinear program gradient. The detection wavelength was 235 nm. Greater than 3000; the limit test for glyburide was performed on a Hypersil ODS C18 column (4.6 mm × 200 mm, 5 μm) eluting with methanol: ammonium dihydrogen phosphate solution at a detection wavelength of 230 nm with a theoretical plate number greater than 6,000. Results: In the HPLC qualitative identification of Xiaoke Pills, the dextromethorphan tablets were identified by HPLC with the standard of Schisandrin, puerarin and glyburide as reference materials. The detection limit of glyburide was 50.2 ng / ml. Conclusion: It is indicated that the method is simple and easy to operate with strong specificity and good reproducibility. It can be used for the quality control of Xiaoke Pills.