HPLC检测他克莫司软膏剂中他克莫司的含量

Content determination of tacrolimus ointment by HPLC

目的建立并验证高效液相色谱法检测他克莫司软膏中他克莫司的含量。方法 Ultimate XB-Di-ol色谱柱(4.6 mm×250 mm,5μm);流动相为正己烷-正丁基氯-乙腈;检测波长225 nm;流速1.7 mL/min;温度:室温。结果他克莫司的线性范围Y=2 600.7X-583.82,相关系数为0.999 9,线性范围为2 mg/L^200 mg/L,平均回收率为98.97%,RSD为0.47%。结论本方法简便、灵敏、准确、重现性好、专属性强,可用于药厂对他克莫司软膏剂中他克莫司的测定。

Objective To develop a HPLC method for determination tacrolimus.Methods The analysis was carried on a Ultimate XB-Diol（4.6×250 mm,5μm）column.The mobile phase was composed of hexane,1-butyl chloride,and acetonitrile and the flow rate was 1.7 mL/min.The detection wavelength was set at 225 nm and column temperature was ambient temperature.Results The linear range of tacrolimus was 2-200 μg/ml（r=0.9999）and the linear equation was Y=2600.7X-583.82.The average recovery（n=7）was 98.7%,and RSD was 0.47%.Conclusion This method with strong specificity is simple,sensitive,accurate,reproducible,and can be used for the determination of tacrolimus.