HPLC快速检测药品的研究思路及其在降糖类药品中的应用

目的:阐明高效液相色谱法快速检测药品的思路和方法,为后续高效液相色谱快速检测药品方法研究提供参考。 方法:采用HPLC,DAD检测器,C₁₈或C₈色谱柱,通过相对保留时间和光谱相似度2个指标对药品活性成分进行定性;同一类的活性成分结构相近的药品,使用这一类药品中的1个作为公用对照物质,采用相对校正因子进行定量,实现标准物质数字化,在实际工作中不用或者少用对照品,从而达到药品快速检验的目的。 结果:用该方法研究思路建立了降糖类药品(二甲双胍、苯乙双胍、格列吡嗪、甲苯磺丁脲、格列本脲、那格列奈、格列喹酮、瑞格列奈、格列齐特、罗格列酮、吡格列酮、格列美脲)快速检测方法并对实际样品进行了检测。 结论:方法不需要使用大量的对照品,适用于药品的快速检测,提出了高效液相色谱法快速检测药品的研究思路。

Objective: To clarify ideas and methods for the rapid drug detection by HPLC,and to provide reference for future studies. Methods: HPLC with DAD detector was applied using a C₁₈ or C₈ column.The qualitative analysis is performed by both relative retention time and spectral similarity.For the active ingredients with similar structure,one compound was chosen as the replaced standard,and then relative correction factor qualification method was performed to achieve digital reference standards.To achieve the purpose of rapid drug-testing,the practical work were usually carried out with less or even without reference standards. Results: An HPLC method was established for the rapid determination of 12 hypoglycemic drugs including metformin,phenformin,glipizide,tolbutamide,glyburide,nateglinide,gliquidone, repaglinide,gliclazide,rosiglitazone,pioglitazone,glimepiride.Real samples were determined using above-mentioned method. Conclusion: The established method is rapid,easy and does not require a large number of reference substances,which is suitable for the rapidly determination of drugs.Collectively,the present study puts forward research idea for rapidly determination of drugs by HPLC.