摘要
目的:用高效液相色谱法测定聚对二甲苯覆膜胶塞中残留二聚对二甲苯的含量。方法:胶塞样品经丙酮提取,溶剂回收浓缩后经乙醇转移定容,进行方法学研究并确定实验条件。色谱条件:HP Hypersil ODS C -18为色谱柱(4.0 mm×125 mm,5μm),流动相为MeOH:H_2O(83:17),流速为1.0 mL/min,检测波长为224 nm。结果:在0.1～2.0 mg/L范围内,进样量与峰面积的线性关系良好(r=0.9999),24 h内稳定性试验的RSD为0.6%,回收率为101.14%(RSD=0.8%,n=9),最低检测限为4.0×10^(-10)g。结论:该方法快捷,准确,适用于聚对二甲苯覆膜胶塞中残留二聚对二甲苯的含量测定。
Objective： To determine residual di-paraxylylene in parylene film coated rubber closure by HPLC. Methods： Parylene film coated rubber closures were extracted with acetone, which then evaporated and transferred with ethanol to volumetric flask, the validation of the method was tested and the test condition was confirmed. The chromatography condition was with HP Hypersil ODS C18 column （4.0 mm × 125 mm,5μm）, mobile phase was methanol ： water（87 ： 13）, flow speed was 1.0 mL/min, detection wavelength was 224 nm. Results： The peak area of di - paraxylylene correlated well to injection mass in range of 0.1 - 2.0 mg/L. The stability （RSD） was 0.6% in 24 h. The recoveries were 101, 14% （RSD =0. 8% , n =9）. The limit of detection was 4.0 × 10^-10g. Conclusion： The method was fast and accurate, and suitable for determining the content of residual di - paraxylylene in parylene film coated rubber closure.
出处
《药学实践杂志》
CAS
2007年第4期235-237,共3页
Journal of Pharmaceutical Practice
