HPLC法测定环孢素胶囊及软胶囊的含量及有关物质

Determination of the content and related substances of cyclosporin capsules and soft capsules by HPLC

目的 建立以高效液相色谱法（HPLC）测定环孢素胶囊及软胶囊的含量及有关物质的方法.方法 色谱柱用十八烷基硅烷键合硅胶作为填充剂,以四氢呋喃-0.05mol/L磷酸溶液（45：55）为流动相;流速为1.0mL/min;柱温为75℃;检测波长220nm;进样量10μL.结果 以环孢素浓度（C）对峰面积（A）进行回归分析,得回归方程为A=10.304C＋1.2175,r=0.9999;在检测浓度为0.25～9.90μg/mL范围内呈良好线性关系;环孢素的检出限3ng,定量限9.9ng.结论 采用HPLC法测定环孢素胶囊及软胶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.

Objective To establish the HPLC method for the determination of content and related substancesof cyclosporin capsules and soft capsules. Methods C18（250mm×4.6mm, 5μm） column was used as the stationary phase. The mobile phase consisted of tetrahydrofuran -0.05mol/L phosphate （45：55） and the flow rate of 1.0mL/min. The column temperature was 75℃ and the detection wavelength was 220nm. The injection volume was 10μL. Results The linear range of rocuronium bromide was 0.25-9.90μg/mL（A=10.304C＋1.2175, r=0.9999）. Limit of detection for cyclosporin was 3ng. Limit of quantitation for cyclosporin was 9.9ng. Conclusion The method was specificity, sensitivity and reliable for content determination of cyclosporin capsules and soft capsules.