离子色谱法测定酒石酸长春瑞滨中三氟乙酸残留  

Ion chromatography determination of trifluoroacetic acid residue in vinorelbine tartrate

作　　者：冯顺卿[1] 李咏华 李晓燕[1] 黄仲立[1] 

机构地区：[1]中山大学测试中心,广州510275 [2]广州汉方现代中药研究开发有限公司,广州510970

出　　处：《药物分析杂志》2013年第2期289-291,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:研究运用离子色谱法测定酒石酸长春瑞滨中三氟乙酸残留。方法:采用IonPac AS11-HC(4 mm×250 mm)分析柱以及相应的保护柱IonPac AG11-HC(4 mm×50 mm),以30 mmol.L-1氢氧化钠-水(40∶60)作为淋洗液,流速1.30 mL.min-1,抑制电导检测。柱温30℃,进样体积100μL。结果:三氟乙酸与样品中其他成分达到良好分离,其质量浓度在0.05-10.0 mg.L-1范围内与峰面积具有良好的线性关系(r=0.9992)。其检出限为0.02 mg.L-1,定量限为0.05 mg.L-1。结论:该方法适用于酒石酸长春瑞滨药物中三氟乙酸残留量的测定。Objective：To develop an ion chromatography （IC） method for residue determination of trifluoroacetic acid （TFA）in vinorelbine tartrate. Methods ：The determination was performed on an IonPac ASI 1 -HC analytical column（4 mm ×250 ram）with an AGll - HC guard column（4 mm ×50 ram）. The eluent was 30 mmol· L^-1 sodi- um hydroxide - H20（40： 60） at a flow rate of 1.3 mL · min^-1 TFA was detected by suppressed conductivity. The column temperature was 30 ℃ and the injection volumn was 100 μL. Results： A good linear relationship was found between the peak area and the concentration of TFA within the range of 0.05 mg to 10. 0 rag（ r = 0. 9992）. Limit of detection （LOD） and limit of quantification （LOQ） for TFA was 0. 02 mg and 0. 05 rag, respectively. Conclusion： The method can be used for the determination of TFA residue in vinorelbine tartrate.

关 键 词：离子色谱法 电导 酒石酸长春瑞滨 三氟乙酸 杂质残留 抗肿瘤药物 

分 类 号：R917[医药卫生—药物分析学]