HPLC法测定洛索洛芬钠凝胶贴膏中克罗米通的含量

Determination of crotamiton in loxoprofen sodium cataplasms by HPLC

目的采用高效液相色谱法,建立洛索洛芬钠凝胶贴膏中克罗米通的含量测定方法。方法色谱柱为Elite Hypersil ODS2(5μm,4.6 mm×150 mm);流动相为磷酸盐缓冲液[含体积分数1%三乙胺的磷酸二氢钾溶液(0.05 mol·L^-1),用磷酸调节pH值至4.0]-乙腈(体积比60︰40);检测波长为242 nm;流速为1.0 mL·min^-1;进样量为20μL。结果克罗米通质量浓度在52.58~315.45 mg􀁷L-1范围内呈现良好的线性关系,回归方程:A=4.4656×10^4C+4.2638×10^4(r=1.000),平均加样回收率为100.8%,RSD为0.91%(n=9)。结论该方法快速、操作简便,方法的专属性好、准确度高,可用于洛索洛芬钠凝胶贴膏中克罗米通的含量测定。

Objective To establish a method for the determination of crotamiton in loxoprofen sodium cataplasms by high performance liquid chromatography(HPLC).Methods The column was Elite Hypersil ODS2(5μm,4.6 mm×150 mm);The mobile phase was phosphate buffer(0.05 mol·L-1 potassium dihydrogen phosphate solution containing 1%triethylamine,pH was adjusted to 4.0 with phosphoric acid)-acetonitrile(V︰V=60︰40);The detection wavelength was at 242 nm;The flow rate was 1.0 mL·min^-1;The injection volume was 20μL.Results The concentration of crotamiton showed a good linear relationship in the range of 52.58~315.45 mg·L^-1.The regression equation:A=4.4656×10^4C+4.2638×10^4(r=1.000),the average recovery rate was 100.8%,and the RSD was 0.91%(n=9).Conclusion The method is rapid and easy to operate with good specificity and high accuracy.It can be used for the determination of crotamitonin loxoprofen sodium cataplasms.