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血浆中普伐他汀的高效液相色谱测定法

High-performance liquid chromatography determination of pravastatin in plasma.

作者信息

Iacona I, Regazzi M B, Buggia I, Villani P, Fiorito V, Molinaro M, Guarnone E

机构信息

Department of Pharmacology, I.R.C.C.S. Policlinico S. Matteo, Pavia, Italy.

出版信息

Ther Drug Monit. 1994 Apr;16(2):191-5. doi: 10.1097/00007691-199404000-00014.

DOI:10.1097/00007691-199404000-00014
PMID:8009569
Abstract

Pravastatin is a 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor that reduces plasma cholesterol levels. Some analytical methods have been described for determination of pravastatin levels in biological fluids, but these methods are rather cumbersome and involve expensive specialized equipment, usually not available in a clinical setting. A new technique, reversed-phase high-performance liquid chromatography (HPLC) with ultraviolet (UV) detection capability, has been developed for the analytical determination of pravastatin in plasma. Extraction and sample clean-up procedures are simple and rapid to execute, yet yield chromatograms virtually free of interference from endogenous plasma constituents and other antihypercholesterolemic agents or drugs usually taken concomitantly with pravastatin. Our detection limit for pravastatin was 2 ng/ml. Standard curves were linear between 5 and 200 ng/ml, with a coefficient of variation (CV) of < 10% at the limits of quantitation. This method was used to study pravastatin plasma levels in two hypercholesterolemic heart-transplant recipients and two hypercholesterolemic nontransplanted patients. We conclude that the method reported here would be ideal for therapeutic pravastatin monitoring in patients.

摘要

普伐他汀是一种3-羟基-3-甲基戊二酰辅酶A还原酶抑制剂,可降低血浆胆固醇水平。已经描述了一些用于测定生物流体中普伐他汀水平的分析方法,但这些方法相当繁琐,且需要昂贵的专用设备,而这些设备在临床环境中通常并不具备。一种具有紫外(UV)检测能力的反相高效液相色谱(HPLC)新技术已被开发用于分析测定血浆中的普伐他汀。提取和样品净化程序执行简单且快速,所得色谱图几乎不受内源性血浆成分以及通常与普伐他汀同时服用的其他降胆固醇药物或药物的干扰。我们测定普伐他汀的检测限为2 ng/ml。标准曲线在5至200 ng/ml之间呈线性,定量限处的变异系数(CV)<10%。该方法用于研究两名高胆固醇血症心脏移植受者以及两名高胆固醇血症非移植患者的普伐他汀血浆水平。我们得出结论,本文报道的方法对于患者治疗中普伐他汀的监测将是理想的。

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