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本文建立了工业上用高效液相色谱法测定一次性输液器内增塑剂DEHP的溶出量。使用ZORBAX Eclipse XDB-C18柱(250mm×4.6 mm id;5um)流动相为甲醇。流速为1ml/min,柱温为35℃,检测波长为272nm。在此条件下DEHP在浓度为2到200mg/L与色谱峰面积值呈良好的线性关系,回归系数均在0.9999以上。HEHP溶出量测定的相对标准偏差(n=6)为0.174%。加标回收率在99.9~104.3%。此测定的方式较为简单、准确,可用于一次性输液器内增塑剂DEHP溶出量的测定。更为重要的是,将创新地运用RFID技术,对测定的数据分析,着力地优化检测的流程,以实现高效测定DEHP的溶出量,并在后期对数据加以跟踪。
In this paper, the establishment of a commercially available high performance liquid chromatography determination of disposable infusion device plasticizer DEHP dissolution. The mobile phase was methanol using a ZORBAX Eclipse XDB-C18 column (250 mm × 4.6 mm id; 5 μm). The flow rate was 1 ml / min, the column temperature was 35 ° C, and the detection wavelength was 272 nm. Under these conditions, DEHP showed a good linear relationship between the concentration of 2 and 200 mg / L and the chromatographic peak area, and the regression coefficients were above 0.9999. The relative standard deviation (n = 6) of HEHP dissolution was 0.174%. Spike recovery was 99.9 ~ 104.3%. The determination of the method is relatively simple and accurate, can be used for one-time infusion of plasticizer DEHP dissolution determination. More importantly, RFID technology will be used in an innovative way to analyze the measured data and to optimize the testing process so as to efficiently measure the amount of DEHP eluted and to track the data later.