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高效液相色谱法紫外检测法测定莫西沙星:方法验证及在中国人志愿者的药代动力学研究中的应用。

High performance liquid chromatography assay with ultraviolet detection for moxifloxacin: validation and application to a pharmacokinetic study in Chinese volunteers.

机构信息

Department of Clinical Pharmacy, Futian People's Hospital, Guangdong Medical College, Shenzhen, China.

出版信息

J Chromatogr B Analyt Technol Biomed Life Sci. 2010 Dec 15;878(32):3437-41. doi: 10.1016/j.jchromb.2010.10.024. Epub 2010 Oct 30.

Abstract

A specific, sensitive and widely applicable high performance liquid chromatography with ultraviolet detection (HPLC-UV) method for the determination of moxifloxacin in human plasma was developed and validated in this study. The method involved a single step of liquid-liquid extraction with dichloromethane and the extraction yields more than 80% were achieved. The separation was performed on a common Kromasil C(8) column with an isocratic mobile phase. The total time was within 10 min per run. The calibration curve for moxifloxacin was linear in the concentration range of 0.05-5.0 μg/ml with correlation coefficient of 0.9997. The developed method was validated with excellent specificity, sensitivity, accuracy, precision and stability. Using this developed method, the pharmacokinetics of moxifloxacin in healthy Chinese volunteers was studied.

摘要

本研究建立并验证了一种专属性强、灵敏度高、适用性广的高效液相色谱-紫外检测法(HPLC-UV),用于测定人血浆中的莫西沙星。该方法采用二氯甲烷一步液-液萃取,萃取率超过 80%。分离在常用的 Kromasil C(8)柱上进行,采用等度洗脱。每个运行时间在 10 分钟以内。莫西沙星的校准曲线在 0.05-5.0μg/ml 浓度范围内呈线性,相关系数为 0.9997。所建立的方法具有良好的特异性、灵敏度、准确性、精密度和稳定性。使用该方法研究了莫西沙星在中国健康志愿者中的药代动力学。

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