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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 rapid HPLC method for the determination of isoniazid, pyrazinamide, sodium p-aminosalicylate, ethionamide, prothiocarb, rifampicin, rifapentine and rifabutin for anti-TB drugs Confirmation method. Methods AlltimaTMHP C18Rocket TM columns were used. The above compounds were divided into three groups according to their physical properties, and the chromatographic separation system of each group of compounds was determined. The relative capacity factor and UV spectral similarity index were used for qualitative analysis. The relative capacity factor method was used for quantitative analysis . Results Based on the physical properties or structure of the compounds, they were grouped and the chromatographic separation system for each group of compounds determined to separate as many compounds as possible with fewer chromatographic systems, to reduce mobile phase switching during HPLC analysis and to speed up drug analysis Speed; Qualitative using double indicators, increased the accuracy of HPLC qualitative; Relative correction factor content assay, can effectively reduce the use of reference substance, to speed up the HPLC analysis speed. Conclusion The method of rapid confirmation of anti-tuberculosis drugs by HPLC is rapid and simple, which is suitable for the rapid detection of drugs and provides the guidelines for the rapid detection of drugs by HPLC.