HPLC法测定维A酸软膏中维A酸含量

Determination of Tretinoin in Tretinoin Ointment by HPLC

目的建立维A酸软膏中维A酸含量测定的方法。方法采用ZORBAX ODS色谱柱(250 mm×4.6 mm,5μm),以甲醇-2%冰醋酸(85:15)为流动相,流速1.0 ml·min^(-1),检测波长346 nm,柱温:45℃。结果维A酸浓度在1.0~8.0μg·ml^(-1)范围内与峰面积呈良好的线性关系,线性回归方程为A=158.1 C+4.159(r=1.0000,n=6),平均回收率为99.50%,RSD为0.97%(n=9)。结论本方法的精密度、重复性、稳定性良好,可用于维A酸软膏制剂含量测定。

Objective To establish a method for determining the content of tretinoin in tretinoin ointment. Methods HPLC assay was carried out on Agilent ZORBAX ODS （250 mm × 4.6 mm,5 μm） column with metha- nol-2% glacial acetic acid solution （85：15 ） used as the mobile phase. The sample was detected at 346 nm with an UV detector. The column temperature was set at 45℃ and the flow rate was 1.0 ml ·min ^- 1. Results A good linearity was obtained over the range of 1.0 -8.0 μg·m1^-1 , A = 158.1 C ＋4. 159（ r = 1. 0000, n =6）. The average recovery of tretinoin ointment was 99.50%, and the RSD was 0.97% （ n = 9）. Conclusion This method is suitable for the assay of tretinoin ointment preparation with good precision, reproducibility and stability.