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