摘要
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.
出处
《药学服务与研究》
CAS
CSCD
2010年第1期21-23,共3页
Pharmaceutical Care and Research
基金
国家"重大新药创制"专项(No.2009ZX09502-010)
关键词
川利明涂剂
盐酸川芎嗪
盐酸利多卡因
盐酸苯海拉明
色谱法
高压液相
Chuanliming paint
ligustrazine hydrochloride
lidocaine hydrochloride
diphenhydramine hydrochloride
chromatography
high pressure liquid