摘要
建立了高效液相色谱法测定培美曲塞二钠原料药有关物质的方法。采用Zorbax SB-C8(4.6 mm i.d.×150 mm,3.5μm)色谱柱,以0.025 mol/L乙酸钠溶液(用冰乙酸调p H至5.5)为流动相A,乙腈为流动相B,梯度洗脱,流速为1.0 m L/min;柱温35℃;检测波长250 nm;进样体积20μL。在该条件下主成分与有关物质的分离度良好,在测定的范围内具有良好的线性关系(相关系数r>0.999)、精密度和稳定性。方法能够对培美曲塞二钠原料药的主要杂质进行有效的分离和检测,可用于该产品的质量控制。
To establish a method for determination of the related substances of pemetrexed disodium. An HPLC gradient elution method and Zorbax SB-Cs （4.6 × 150 mm, 3.5 μm） column was used in this study. The mobile phase A was 0. 025 mol/L sodium acetate （adjusted to pH 5.5 with acetic acid） and mobile phase B was acetonitrile. The flow rate was set as 1.0 mL/min, the column temperature was 35 ℃ , the detection wavelength was 250 nm and the injection volume was 20 μL. High resolution was obtained between the peaks of main content and related species. This method also exhibited good linearity （correlation coefficients r 〉 0. 999） in the detection range, excellent precision and high stability. With the high specificity, sensitivity and repeatability, this method can be applied to the efficient separation and detection of the impurities in pemetrexed disodium, which is promising in the quality control of this medication.
出处
《分析试验室》
CAS
CSCD
北大核心
2015年第9期1018-1021,共4页
Chinese Journal of Analysis Laboratory
基金
国家手性制药工程技术中心创新平台建设专项(2008ZHZX1A0902)资助
