反相高效液相色谱法测定皮炎消乳膏中多塞平的含量

Determination of Doxepin Hydrochloride in Piyanxiao Cream by RP-HPLC

目的建立皮炎消乳膏中多塞平的含量测定方法。方法反相高效液相色谱法,岛津ODS C18柱,(4.6 mm×150mm,5μm);流动相:甲醇-水(80∶20);检测波长:280 nm;流速:1.0 ml.min-1;柱温:30℃。结果多塞平进样量在0.1-1.0μg范围内与其峰面积呈良好线性关系,Y=1.472×10-6X+2.142×10-4,r=0.999 9,平均回收率为97.14%,RSD=1.90%。结论该方法简单、快速、准确,可用于该制剂的质量控制。

Objective To establish an RP - HPLC method for determination of the content of doxepin hydrochloride in Piyanxiao cream . Methods Shimazu ODS C18 column （5μm, 4.6mm × 150mm） was used at 30℃. The mobile phase was composed of 80% methanol and 20% water. The detection wavelength was 280nm. The flow rate was 1.0 ml·min^-1. Results The calibration curve was linear in the range from 0.1 to 1.0μg of doxepin hydrochloride. The curve equation was Y= 1. 472 × 10^-6X ＋ 2. 142 × 10^-4 ,r=0. 999 9. The average recovery and the relative standard deviation of doxepin hydrochloride were 97. 14% and 1.90% respectively. Conclusion The method is simple, rapid,accurate and can be used for quality control of the preparation.