高效液相色谱法测定他克莫司滴眼液的含量  

Content determination of tacrolimus eye drops by HPLC

作　　者：王延东[1] 陈茂玲[1] 梁光江[1] 唐细兰[1] 叶成添[1] 

机构地区：[1]中山大学中山眼科中心药剂科,510060

出　　处：《中国实用医药》2009年第30期53-54,共2页China Practical Medicine

摘　　要：目的建立测定他克莫司滴眼液含量的高效液相色谱法。方法采用Diamonsil C18(250mm×4.6mm,5μm)为色谱柱;流动相为乙腈-水-磷酸(600:400:1);流速为2.0ml/min;检测波长为215nm;柱温为50℃。结果他克莫司在6.25～200mg/L浓度范围内线性关系良好(r=0.9999),平均回收率为99.68%,RSD为0.78%,方法重现性的RSD为1.28%(n=6)。结论该方法简便、快速、灵敏,可用于该制剂的质量控制。Objective To establish a HPLC method for the content determination of tacrolimus eye drops.Methods The separation was performed on Diamonsil C18（250 mm×4.6 mm,5 μm）,the mobile phase was acetonitrile-water-phosphonic acid（600：400：1）with the flow rate of 2.0 ml/min,the detection wavelength was at 215 nm and column temperature was 50℃.Results The calibration curve of tacrolimus was linear within the concentration range of 6.25～200 mg/L,r=0.9999.The average recovery rate of tacrolimus was 99.68%（RSD=0.78%）,and the RSD of the repeatability test was 1.28% （n = 6）. Conclusion The method is sim- ple, rapid,accurate and sensitive,and suitable for the quality contorl of tacrolimus eye drops.

关 键 词：高效液相色谱法 他克莫司 滴眼液 含量测定 

分 类 号：R927.2[医药卫生—药学]