Abstract：Objective To establish the HPLC method for determination related substances of Adapalene in Adapalene Gel.Methods Chromatographic column ORBAX Eclipse XDB-C18(4.6 mm×250 mm,5 μm)was used,and the mobile phase A was glacial acetic acid-water(0.1∶100),and the mobile phase B was acetonitrile-tetrahydrofuran(65∶35)to conduct the gradient elution.The wavelength of detection was 270 nm,the temperature of column was 30°C,the sampling amount was 100 μl,and the flow rate was 1.2 ml/min.Results Adapalene was well separated from various impurity.The solution of Adapalene Gel was stable in 12 hours.The limit of quantification of impurity A,B,C and D was 0.38 ng,0.56 ng,3.75 ng and 1.5 ng respectively,and the detection limit was 0.11 ng,0.17 ng,1.12 ng and 0.45 ng.Adapalene showed a good linear relationship between peak area and concentration in the concentration range of 0.0225-0.1125 g/ml,and the regression equation was y=9.9714x+0.003906(r=0.9998).Conclusion This method is simple and feasible to determine the related substances of Adapalene in Adapalene Gel.
朱雅莲;肖学成;崔开宇;王晓飘. HPLC法测定阿达帕林凝胶中阿达帕林有关物质[J]. 中国当代医药, 2018, 25(9): 20-24.
ZHU Ya-lian;XIAO Xue-cheng;CUI Kai-yu;WANG Xiao-piao. Determination of Adapalene related substances in Adapalene Gel by HPLC. 中国当代医药, 2018, 25(9): 20-24.
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