利拉萘酯乳膏含量测定方法学的探讨

Determination of the content of liranaftate cream

目的建立RP-HPLC法测定利拉萘酯乳膏中利拉萘酯的含量。方法采用Agilent C18色谱柱（150 mm×4.6 mm,5μm）,流动相为乙腈-水（65∶35）,柱温为35℃,检测波长为284 nm,流速为1.2 mL.min-1。结果利拉萘酯在40~200μg.mL-1与峰面积线性关系良好（r=0.999 9）,平均回收率99.1%,RSD为0.86%。结论该方法简便、快速、准确、灵敏度高、重复性好,可用于利拉萘酯乳膏含量的测定。

Objective To establish an RP-HPLC method to determine the content of liranaftate cream. Methods Agi- lent C18 （150 min×4.6 mm, 5μm） was used, the mobile phase was acetonitribe-water （65 ： 35） , the temperature was 35 ℃, and the detective wavelength was 284 nm at 1.2 mL·min^-1. Results The linear range of liranaftate was 40--200μg·mL^-1 （r=0. 999 9）, the average recovery was 99.1%（RSD=0. 86%）. Conclusion The method is convenient, fast, accurate, and sensitive. The reproducibility is high for the content determination of liranaftate cream.