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建立一种采用高效液相色谱-紫外检测法同时测定肿瘤药物制剂中长春新碱和阿霉素的分析方法。

Development of an analytical methodology for simultaneous determination of vincristine and doxorubicin in pharmaceutical preparations for oncology by HPLC-UV.

作者信息

Rodrigues Ana Sofia, Lopes Ana Rita, Leão Ana, Couceiro Alda, Ribeiro Ana Bela Sarmento, Ramos Fernando, Noronha da Silveira Maria Irene, Resende de Oliveira Catarina

机构信息

Grupo de Bromatologia-Centro de Estudos Farmacêuticos, Faculdade de Farmácia da Universidade de Coimbra, 3000-295 Coimbra, Portugal.

出版信息

J Chromatogr Sci. 2009 May-Jun;47(5):387-91. doi: 10.1093/chromsci/47.5.387.

Abstract

A high-performance liquid chromatography-UV methodology (lambda=230 nm) was developed and validated for the simultaneous determination of vincristine and doxorubicin in pharmaceutical preparations used in oncology. The chromatography was carried out on a C18 column using acetonitrile 90% in water-potassium hydrogenphosphate buffer 50 mM, pH 3.2+/-0.1 (32:68, v/v) as mobile phase at a flow rate of 1.5 mL/min. The method proved to be specific, exact, and accurate, in accordance with the ICH standards, presenting linearity in the 1-5 microg/mL and 5-100 microg/mL intervals, and detection (0.19x0.51 microg/mL) and quantification (0.63x1.7 microg/mL) limits for vincristine and doxorubicin, respectively.

摘要

开发并验证了一种高效液相色谱 - 紫外检测方法(波长λ = 230 nm),用于同时测定肿瘤学用药物制剂中的长春新碱和多柔比星。色谱分析在C18柱上进行,以90%乙腈 - 50 mM磷酸氢二钾缓冲液(pH 3.2 ± 0.1,32:68,v/v)作为流动相,流速为1.5 mL/min。根据国际协调会议(ICH)标准,该方法具有特异性、精密性和准确性,在1 - 5 μg/mL和5 - 100 μg/mL区间呈线性,长春新碱和多柔比星的检测限分别为(0.19×0.51 μg/mL)和定量限分别为(0.63×1.7 μg/mL)。

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