高效液相色谱法分离与测定盐酸多塞平顺反式异构体的含量

Separation and Determination of ZE-Doxepin Hydrochloride by HPLC

目的建立盐酸多塞平乳膏中盐酸多塞平顺反式异构体分离与含量测定的高效液相色谱法。方法色谱柱采用Kromasil 100A C18柱（150 mm×4.6 mm,5μm）,流动相为含0.1%三乙胺的0.2 mol/L磷酸二氢钠溶液-甲醇（65∶35）,流速为1.0 m L/min,检测波长为254 nm,柱温为50℃。结果盐酸多塞平质量浓度在7.90~12.66μg/m L范围内与峰面积呈良好线性关系（r=0.999 9）,平均回收率为98.88%,RSD为1.32%（n=9）。结论该方法能良好地分离盐酸多塞平顺反式异构体,可作为盐酸多塞平乳膏中盐酸多塞平的质量控制方法。

Objective To establish a method for the separation and determination of Doxepin Hydrochloride in Doxepin Hydrochloride Cream by HPLC. Methods Chromatography was performed on a Kromasil 100 A C18（ 150 mm × 4. 6 mm, 5 μm） column. The mobile phase was consisted of 0. 1% triethylamine in 0. 2 mol / L sodium dihydrogen phosohate solution- methanol（ 65 ∶ 35）. The flow rate was1. 0 m L / min. The detection wavelength was 254 nm. The column temperature was 50 ℃. Results The linear response range was 7. 90 ~12. 66 μg / m L for Doxepin Hydrochloride（ r = 0. 999 9）. The recovery of Doxepin Hydrochloride was 98. 88%（ RSD = 1. 32%,n = 9）.Conclusion The method can separate ZE- doxepin hydrochloride,which was suitable for the determination of Doxepin Hydrochloride in doxepin hydrochloride cream.