抗艾滋药物茚地那韦、利托那韦和洛匹那韦快速检验方法的研究

Research on the Fast Testing Method for Anti-HIV Drugs of Indinavir,Ritonavir and Lopinavir

目的建立抗艾滋药物茚地那韦、利托那韦和洛匹那韦的HPLC快速检验方法。方法采用GRACE prevail C18色谱柱(7mm×53mm,3μm),以0.02mol·L-1磷酸二氢钾-甲醇(3070)为流动相,流速:2.0mL·min-1,柱温30℃。采用相对容量因子和紫外光谱相似度双指标进行定性;相对校正因子法进行定量分析。结果在上述条件下,茚地那韦、利托那韦和洛匹那韦完全分离,可采用一个色谱体系实现对3种药物的分析;采用双指标(紫外光谱相似度和相对容量因子)进行定性,结果准确可靠;相对校正因子含量测定法,能有效减少对照品的使用,系统上加快了药品的分析速度。结论抗艾滋药物HPLC快速检验方法快速、简便、准确,可作为近红外快筛技术确证方法。

Objective To establish a fast HPLC confirmatory method for anti-HIV drugs （indinavir, ritonavir, lopinavir）. Methods The analysis was performed on GRACE prevail C18 column （7 mm×53 mm,3tm）, with the mobile phase of 0.02 mol ·L^-1 potassium dihydrogen phosphate-methanol （30 ： 70）. The flow rate was set at 2.0 mL · min^-1 and the column temperature was 30℃. 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 The 3 anti-HIV drugs could be analyzed in one chromatographic system and showed good behavior. 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 rapid drug-testing systematically. Conclusion The method is rapid, simple and accurate, which is suitable for conformation for NIR screening of drugs.