建立 UV/HPLC 法测定人血浆和尿液中苯硝唑的浓度及其在儿科临床研究中的应用。
Development of UV/HPLC methods for quantitative analysis of benznidazole in human plasma and urine for application in pediatric clinical studies.
机构信息
Área de Toxicología, Departamento de Ciencias Biológicas, Facultad de Ciencias Exactas, Universidad Nacional de La Plata. La Plata, Provincia de Buenos Aires, Argentina; Laboratorio de Servicios a la Industria y al Sistema Científico (LaSeISiC), Universidad Nacional de La Plata / Comisión de Investigaciones Científicas de la Provincia de Buenos Aires, Argentina.
出版信息
J Clin Lab Anal. 2013 Sep;27(5):384-90. doi: 10.1002/jcla.21615.
OBJECTIVE
Chagas disease constitutes a major public health problem in Latin America. Correctly designed pharmacokinetic, safety, and bioequivalence studies are desirable in order to fill the knowledge gaps that presently exist on available drugs. It is necessary to develop accurate, simple, reproducible, and sensitive high-performance liquid chromatography (HPLC)/UV methods for the quantization of benznidazole (BNZ) in human plasma and urine for clinical applications, specially in pediatric patients.
METHODS
Quantization of BNZ in human plasma involved freeze-drying and re-suspension in organic solvent followed by reverse phase HPLC with UV detection. Analysis of BNZ in urine involved liquid/liquid extraction followed by reverse phase HPLC with UV detection.
RESULTS
Limits of quantization (LOQ) were 0.32 μg/ml for plasma and 5.2 μg/ml for urine. No metabolite interferences were showed in both methods.
CONCLUSION
The LOQ of methods seems appropriate in pediatric clinical contexts. Both procedures were applied with good results, to the quantization of BNZ in plasma and urine of patients treated for Chagas disease.
目的
恰加斯病是拉丁美洲的一个主要公共卫生问题。为了填补现有药物的知识空白，需要设计正确的药代动力学、安全性和生物等效性研究。需要开发准确、简单、可重现和敏感的高效液相色谱（HPLC）/UV 方法，用于临床应用中定量测定人血浆和尿液中的苯并咪唑（BNZ），特别是儿科患者。
方法
人血浆中 BNZ 的定量包括冷冻干燥和有机溶剂重悬，然后进行反相 HPLC 与 UV 检测。尿液中 BNZ 的分析涉及液/液萃取，然后进行反相 HPLC 与 UV 检测。
结果
定量下限（LOQ）分别为血浆 0.32μg/ml 和尿液 5.2μg/ml。两种方法均未显示代谢物干扰。
结论
方法的 LOQ 似乎适用于儿科临床环境。两种方法均应用于恰加斯病患者的血浆和尿液中 BNZ 的定量，结果良好。
Zotero 插件