聚氯乙烯静脉留置针中邻苯二甲酸二(2-乙基己基)酯含量测定方法的建立及在3种药物中的迁移研究

目的: 建立HPLC法测定聚氯乙烯静脉留置针中增塑剂邻苯二甲酸二(2-乙基己基)酯(DEHP)的含量,并考察DEHP在单硝酸异山梨酯、硝酸甘油及尼莫地平注射液中的迁移情况。 方法: 采用Agilent XDB-C₁₈(4.6 mm×150 mm,5 μm)色谱柱;流动相:甲醇-水(95: 5);流速:1.0 mL·min^-1;检测波长:275 nm;柱温:30℃;进样量20 μL。 结果: DEHP在浓度0.008~1 mg·mL^-1范围内具有良好的线性关系(r=0.9999),平均回收率为93.2%,RSD=1.6%(n=9)。 结论: 本方法灵敏、准确、可靠,可用于聚氯乙烯静脉留置针中DEHP含量及迁移情况的测定。

Objective: To establish an effective HPLC method for determination of di-(2-ethylhexyl)phthalate(DEHP)in polyvinylchloride venous indwelling acus and investigate the migration of DEHP from venous indwelling acus to different injections. Methods: The separation of DEHP was performed with a Agilent XDB-C₁₈ column(4.6 mm×150 mm,5 μm)at 30℃ and the detective wavelength was set at 275 nm.The mobile phase consisted of methanol-water(95: 5)at a flow rate of 1.0 mL·min^-1 and the injection volume was 20 μL. Results: The calibration curve was linear over the concentration ranged from 0.008-1 mg·mL^-1(r =0.9999)and the average recovery was 93.2%(RSD=1.6%,n=9). Conclusion: This method is simple,rapid,accurate and suitable for the determination of DEHP in polyvinylchloride venous indwelling acus and the migration to injection.

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