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他汀类药物药学分析中紫外线与带电气溶胶检测方法的比较

Comparison of UV and charged aerosol detection approach in pharmaceutical analysis of statins.

作者信息

Nováková Lucie, Lopéz Sofía Arnal, Solichová Dagmar, Satínský Dalibor, Kulichová Bohumila, Horna Ales, Solich Petr

机构信息

Department of Analytical Chemistry, Faculty of Pharmacy, Charles University, Heyrovského 1203, 500 05 Hradec Králové, Czech Republic.

出版信息

Talanta. 2009 May 15;78(3):834-9. doi: 10.1016/j.talanta.2008.12.057. Epub 2009 Jan 15.

Abstract

CAD (charged aerosol detector) has recently become a new alternative detection system in HPLC. This detection approach was applied in a new HPLC method for the determination of three of the major statins used in clinical treatment-simvastatin, lovastatin and atorvastatin. The method was optimized and the influence of individual parameters on CAD response and sensitivity was carefully studied. Chromatography was performed on a Zorbax Eclipse XDB C18 (4.6 mm x 75 mm, 3.5 microm), using acetonitrile and formic acid 0.1% as mobile phase. The detection was performed using both CAD (20 pA range) and DAD (diode array detector-238 nm) simultaneously connected in series. In terms of linearity, precision and accuracy, the method was validated using tablets containing atorvastatin and simvastatin. The CAD is designated to be a non-linear detector in a wide dynamic range, however, in this application and in the tested concentration range its response was found to be perfectly linear. The limits of quantitation (0.1 microg/ml) were found to be two times lower than those of UV detection.

摘要

带电气溶胶检测器(CAD)最近已成为高效液相色谱(HPLC)中的一种新型替代检测系统。这种检测方法应用于一种新的HPLC方法,用于测定临床治疗中使用的三种主要他汀类药物——辛伐他汀、洛伐他汀和阿托伐他汀。对该方法进行了优化,并仔细研究了各个参数对CAD响应和灵敏度的影响。使用Zorbax Eclipse XDB C18(4.6 mm×75 mm,3.5微米)色谱柱,以乙腈和0.1%甲酸作为流动相进行色谱分析。检测同时使用串联连接的CAD(20 pA范围)和二极管阵列检测器(DAD,238 nm)。在线性、精密度和准确度方面,使用含有阿托伐他汀和辛伐他汀的片剂对该方法进行了验证。CAD在宽动态范围内被指定为非线性检测器,然而,在本应用和测试浓度范围内,发现其响应呈完美线性。定量限(0.1微克/毫升)比紫外检测的定量限低两倍。

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