HPLC法测定环孢素胶囊及软胶囊的含量及有关物质.pdfVIP

.448. 中国抗生素杂志2016年6月第41 卷第6期 文章编号: 1001-8689(2016)06-0448-05 HPLC法测定环抱素胶囊及软胶囊的含量及有关物质 庞文哲王莱莉宋史中韩彬李香荷王强 (河北省药品检验研究院，石家庄 050000) 摘要:目的 建立以高效液相色谱法(HPLC)测定环抱素胶囊及软胶囊的含量及有关物质的方法。方法 色谱柱用十八 皖基硅皖键合硅胶作为填充剂，以四氢哄喃-0.05mo1/L磷酸溶液(45:55)为流动相;流速为1.0mL/min; 柱温为75.C; 检测披长 22Onm;进样量1O~。结果 以环抱素浓度(。对峰面积(A)进行回归分析，得回归方程为A=10.304C+1.2175. 严0.9999; 在检测 0.25-9. Ilg/mL范围内呈良好线性关系:环抱素的检出限3吨，定量限9.9晤。结论 采用旧LC法测定环抱素股囊及软胶 浓度为 90 囊的含量及有关物质，方法灵敏度高，专属性强，结果准确可靠。 关键词环抱素:有关物质:含量:高效液相色谱法 中图分类号: R979.5 文献标志码:A Determination of the content and related substances of cyclosporin capsules and soft capsules by HPLC PangWen卜-zhe， Wang Mo-li , Song Geng-shen, Han Bin , Li Xiang-he and Wang Qiang (Hebei Institute for Drug Con仕01， Shijiazhuang 050000) Abstract Objective To establish the HPLC method 岛r the determination of content and related substances x of cyclosporin capsules and soft capsules. Methods C (250mm 4血nm， 5μm) column was used as the stationary 1s phase. 咀le mobile phase consisted of te位ahydrofuran -0.05moI!L phosphate (45:55) and the flow rate of 1.0mL/min. 0 The column temperature was 75 C and the detection wavelength was 220nm. The injection volume was 10μL ResuIts The linear range of rocuronium bromide was 0.25-9.90μg/mL(A=10.304C+1.2175， 严0.9999). Limit of detection for cyclosporin was 3ng. Limit of quantitation for cyclosporin was 9.9ng. ConcIusion The method was specificity,sensitivity and reliable for content determination of c