HPLC法测定曲安奈德益康唑乳膏中的有关物质

目的:建立HPLC法测定曲安奈德益康唑乳膏中有关物质的方法.方法:采用高效液相色谱法,色谱条件为:色谱柱以十八烷基硅烷键合硅胶为填充剂(Kromasil 100-5 C18,4.6 mm×250 mm,5 μm),柱温为45 ℃;以0.077％醋酸铵缓冲液(用磷酸调节pH值至3.0)-甲醇(80:20)为流动相A;甲醇...

Determination of Related Substances in Triamcinolone Acetonide and Econazole Nitrate Cream by HPLC

Objective:To establish a method for the determination of related substances in Triamcinolone Acetonide and Econazole Nitrate Cream.Methods:HPLC was used,the chromatographic conditions were as follows:using octadecylsilane bonded silica gel as filler(kromasil 100-5 C18,4.6 mm×250 mm,5μm chromatographic column),column temperature was 45℃;0.077%ammonium acetate buffer(adjusted pH value to 3.0 with phosphoric acid)-methanol(80∶20)as mobile phase A,methanol acetonitrile(40∶60)as mobile phase B,and the flow rate was 1.0 mL/min.The detection wavelength was 240 nm and 225 nm.Results:At 225 nm detection wavelength,the chromatographic peak of negative sample,triamcinolone acetonide peak and impurity peak have no interference on the detection of econazole nitrate and its impurities.The resolution of econazole,Econazole impurity A,impurity B,impurity C,miconazole and unknown impurity peaks and adjacent chromatographic peaks in the test solution with known impurities meet the requirements;at the detection wavelength of 240 nm,the chromatographic peak of negative sample and Yikang nitrate have no interference in the test solution with known impurities,triamcinolone acetonide,impurity A(triamcinolone),impurity B,impurity C and unknown impurity in the test solution with known impurities met the requirements.Conclusion:After the methodological validation of the proposed related substances method,all indicators basically meet the requirements,indicating that the established method is suitable for the detection of related substances in triamcinolone Acetonide and Econazole Nitrate Cream.