用RP-HPLC法同时测定川利明涂剂中3种成分的含量

Simultaneous determination of three ingredients of Chuanliming paint by RP-HPLC method

目的：建立同时测定川利明涂剂中盐酸川芎嗪、盐酸利多卡因和盐酸苯海拉明含量的RP-HPLC法。方法：色谱柱为Kromasil-C18柱（150 mm×4.6 mm,5μm）;流动相为乙腈-0.02 mol/L磷酸二氢钠-三乙胺（37∶63∶0.15）,用磷酸调节pH至3.15,内含0.015 mol/L十二烷基硫酸钠;检测波长220 nm;流速1.0 ml/min。结果：盐酸川芎嗪、盐酸利多卡因和盐酸苯海拉明分别在5-80μg/ml（r=0.999 8）、5.72-91.52μg/ml（r=0.999 9）、5.26-84.16μg/ml（r=0.999 6）范围内线性良好,平均回收率分别为（102.82±0.96）%、（103.21±0.91）%和（103.51±0.68）%（n=3）,日内、日间精密度符合要求。结论：该方法简便、准确,重复性好,适用于川利明涂剂的质量控制。

Objective：To establish a RP-HPLC method for simultaneous determination of ligustrazine hydrochloride,lidocaine hydrochloride and diphenhydramine hydrochloride in Chuanliming paint.Methods：The separation was performed on a Kromasil C18 column（150 mm×4.6 mm,5 μm） with the mobile phase consisting of acetonitrile-0.02 mol/L sodium dihydrogen phosphate-triethylamine（37∶63∶0.15,pH adjusted to 3.15 with phosphoric acid containing 0.015 mol/L sodium dodecyl sulfate）.The detection wavelength was 220 nm.The flow rate was 1.0 ml/min.Results：The standard curves were linear in the range of 5-80 μg/ml for ligustrazine hydrochloride（r=0.999 8）,5.72-91.52 μg/ml for lidocaine hydrochloride（r=0.999 9） and 5.26-84.16 μg/ml（r=0.999 6） for diphenhydramine hydrochloride,respectively.The average recovery rates of ligustrazine hydrochloride,lidocaine hydrochloride and diphenhydramine hydrochloride were（102.82±0.96）%,（103.21±0.91）% and（103.51±0.68）%（n=3）,respectively.The intra-and inter-day RSD fulfilled the requirements of pharmcopeia.Conclusion：The method is simple and accurate with a good reproducibility,and can be used for quality control of Chuanliming paint.