离子色谱法测定酒石酸长春瑞滨中三氟乙酸残留

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100 μL。 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 AS11-HC analytical column(4 mm×250 mm)with an AG11-HC guard column(4 mm×50 mm). The eluent was 30 mmol·L^-1sodium hydroxide-H₂O(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 mg(r=0.9992). Limit of detection (LOD) and limit of quantification (LOQ) for TFA was 0.02 mg and 0.05 mg, respectively. Conclusion: The method can be used for the determination of TFA residue in vinorelbine tartrate.

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