Abstract：Objective To develop a high performance liquid chromatography (HPLC)method for determining related substances in Ketoprofen Gel.Methods Chromatographic colum ZORBAX SB-Phenyl(4.6 mm×250 mm,5 μm)was used,the mobile phase A was 0.15%trifluoroacetic acid acetonitrile solution,and the mobile phase B was 0.15%trifluoroacetic acid solution to conduct the gradient elution.The wavelength of detection was 254 nm,the temperature of column was 30℃,and the flow rate was 1.3 ml/min.Results With the established chromatographic conditions,Ketoprofen was well separated from various impurity.The solution of Ketoprofen Gel was stable within 12 hours,and RSD of each impurity and peak was less than 2%.Conclusion This method has good specificity and can effectively separate the main components and related substances,and can accurately determine the related substances of Ketoprofen in Ketoprofen Gel.
王晓飘;肖学成. 高效液相法测定酮洛芬凝胶中的有关物质[J]. 中国当代医药, 2019, 26(5): 8-11.
WANG Xiao-piao;XIAO Xue-cheng▲. Determination of related substances in Ketoprofen Gel by high performance liquid chromatography. 中国当代医药, 2019, 26(5): 8-11.
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