高效液相法测定酮洛芬凝胶中的有关物质

Determination of related substances in Ketoprofen Gel by high performance liquid chromatography

目的通过高效液相色谱建立酮洛芬凝胶中有关物质的检测方法。方法采用色谱柱ZORBAX SB-Phenyl(4.6 mm×250 mm,5μm),以0.15%三氟乙酸乙腈溶液为流动相A,以0.15%三氟乙酸溶液为流动相B,进行梯度洗脱,检测波长为254 nm,流速为1.3 ml/min;柱温为30℃。结果在所建立的色谱条件下,酮洛芬与各杂质分离度良好,酮洛芬凝胶溶液在12 h内稳定,各杂质及主峰的RSD均<2%。结论本法专属性好,可以有效分离各主成分及有关物质,可以准确测定酮洛芬凝胶中酮洛芬的有关物质。

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,5μm)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.