抗结核药物HPLC快速确证方法的研究  

Research on the Fast HPLC Confirmatory Method for Anti-TB Drugs

作　　者：王金凤[1] 尹利辉[1] 朱俐[1] 杨化新[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2012年第10期1070-1075,共6页Chinese Pharmaceutical Affairs

基　　金：中国全球基金结核病项目(卫生系统加强部分)

摘　　要：目的建立抗结核药物中异烟肼、吡嗪酰胺、对氨基水杨酸钠、乙硫异烟胺、丙硫异烟胺、利福平、利福喷丁、利福布丁等化合物的HPLC快速确证方法。方法采用AlltimaTMHP C18Rocket TM色谱柱;将以上化合物按物理性质分为3组,分别确定每组化合物的色谱分离体系;采用相对容量因子和紫外光谱相似度双指标进行定性;相对容量因子法进行定量分析。结果根据化合物的物理性质或结构,将其分组,确定每组化合物的色谱分离体系,以实现尽可能用较少的色谱体系分离较多化合物,减少HPLC分析过程中流动相的切换,加快药物分析速度;采用双指标进行定性,增加了HPLC定性的准确性;相对校正因子含量测定法,能有效减少对照品的使用,加快HPLC分析速度。结论抗结核药物HPLC快速确证方法快速、简便,适用于药品的快速检测,为HPLC法快速检测药品提供了指导原则。Objective To establish a fast HPLC confirmatory method for Isoniazid,Rifampicin,Pyrazinamide,Sodium Aminosalicylate,Prothionamide,Ethionamide,Rifapentine and Rifabutin detection in anti-TB drugs.Methods AlltimaTMHP C18 RocketTM column was applied.Eight anti-TB drugs were divided into three classes according to their physical properties and the chromatographic system was determined for each class.The qualitation was performed using relative retention time and spectral similarity as the double indicator.The relative correction factor for quantification analysis was used for content determination.Results One matched chromatographic system was used for one class of drugs of similar physical properties in order to accelerate the analysis progress.The qualitation was more accurate by applying the double indicator.The relative correction factor method for quantification which required less reference substances in the on-site screening enabled the rapid drug-testing.Conclusion The method is rapid,simple and does not require a large amount of reference substances,which is suitable for the rapid determination of drugs.It also provides a guiding principle for rapid determination of drugs by HPLC.

关 键 词：抗结核药物 高效液相色谱法 异烟肼 吡嗪酰胺 对氨基水杨酸钠 乙硫异烟胺 丙硫异烟胺 利福平 利福喷丁 利福布丁 快速确证 快检技术 

分 类 号：R916.693[医药卫生—药学] R917