HPLC法同时测定环孢素注射液的含量和有关物质

发布时间：2018-01-17 02:00

  本文关键词：HPLC法同时测定环孢素注射液的含量和有关物质　出处：《中国药房》2015年03期 　论文类型：期刊论文

  更多相关文章： 环孢素 含量测定 有关物质 高效液相色谱法

【摘要】：目的:建立同时测定环孢素注射液含量和有关物质的方法。方法:采用高效液相色谱法。色谱柱为Merck Hibar?C18,流动相为四氢呋喃-0.05 mol/L磷酸溶液(45∶55,V/V),流速为1.0 ml/min,检测波长为220 nm,柱温为75℃,进样量为10μl。结果:环孢素C、环孢素B、环孢素、环孢素G、环孢素H、异环孢素H、异环孢素A质量浓度分别在1.95~195.00、2.03~203.00、0.25~9.90、1.83~182.80、1.26~125.80、1.81~180.80、2.02~202.40μg/ml范围内与各自峰面积积分值呈良好线性关系(r=0.999 9、0.999 9、0.999 9、0.999 9、0.999 9、0.999 8、0.999 9);精密度、稳定性、重复性试验的RSD≤0.3%;环孢素平均回收率为99.94%,RSD=0.10%(n=3)。结论:本方法准确、可靠、灵敏度高、专属性强,可用于环孢素注射液的质量控制。
[Abstract]:Objective: to establish a method for simultaneous determination of cyclosporine injection and its related substances. Methods: high performance liquid chromatography (HPLC) was used. The chromatographic column was Merck Hibar? The mobile phase was tetrahydrofuran -0.05 mol/L phosphoric acid solution with a flow rate of 1.0 ml / min and detection wavelength of 220nm. Results: cyclosporine C, cyclosporine B, cyclosporine, cyclosporine G, cyclosporine H and isocyclosporine H. The mass concentration of isocyclosporine A was 1.95 / 195.00 / 2.033.00 / 0.259.90 / 1.83.90 / 1.82.80 / 1.26 / 125.80 respectively. There was a good linear relationship between the integral value of the peak area in the range of 1.81g / ml, 180.80,2.02g / ml, 202.40 渭 g / ml and their respective peak area. 0.999 9, 0.999 9, 0.999 9, 0.999 8, 0.999 9; Precision, stability, repeatability test RSD 鈮，

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