HPLC法同时测定复方苯海拉明麻黄碱糖浆三组分的含量

目的建立HPLC法同时测定复方苯海拉明麻黄碱糖浆中盐酸苯海拉明、盐酸麻黄碱和枸橼酸喷托维林的含量。方法采用HPLC法,色谱柱为AgilentC18柱,以乙腈和0.5%三乙胺（用磷酸调节pH=3.0）为流动相,流速1.0mL·min^-1,梯度洗脱;检测波长210nm;外标法定量。结果盐酸苯海拉明在20.50～205.00μg·mL^-1围内呈良好线性关系（r=0.99999）,回收率为100.21%,RSD=0.57%;盐酸麻黄碱在19.95～199.50μg·mL^-1围内呈良好线性关系（r=0.9999）,回收率为100.14%,RSD=0.94%;枸橼酸喷托维林在15.75～157.50μg·mL^-1围内呈良好线性关系（r=0.9999）,回收率为99.83%,RSD=0.64%。结论本方法灵敏可靠,结果准确,可用于复方苯海拉明麻黄碱糖浆的质量控制。

Simultaneous Determination of Diphenhydramine Hydrochloride ,Ephedrine Hydrochloride and Pentoxyverine Citrate in Compound Diphenhydramini Ephedrine Syrup by HPLC

Objective To determine the content of diphenhydramine hydrochloride, ephedrine hydroehioride and pentoxyverine citrate in Compound Diphenhydramini Ephedrine Syrup hy HPLC. Methods Agilent C18 was used and the mobile phase was used acetonitrile and 0.5 % triethylamine （pH = 3.0）, and the flow rate was 1.0mL · min^-1 with gradient elution and the detection wavelength was 210nm. The external standard method was used to determine the content of diphenhydramine hydrochloride, ephedrine hydrochloride and pentoxyverine citrate. Results The linear ranges was 20.50-205.5μg · mL^-1 for diphenhydramine hydrochloride （r = 0. 9999） The average recovery rate of diphenhydramine hydrochloride was 100.21%. The RSD was 0. 57%. The linear ranges was 19.95-199μg · mL^-1 for ephedrine hydrochloride （r = 0. 9999） . The average recovery rate of ephedrine hydrochloride was 100. 14%. The RSD was 0.94%. The average recovery rate of pentoxyverine citrate was 99.83%. The RSD was 0. 64%. The linear ranges was 15. 754157.5μg · mL^-1 for pentoxyverine citrate （r=0. 9999） . Conclusions This method is sensitive and believable. It can be effectively used for the quality control of Compound Diphenhydramini Ephedrine Syrup.