RP-HPLC测定红花W/O型乳膏剂中羟基红花黄色素A的含量  

Determination of hydroxylsafflower yellow A in safflower W/O cream by RP-HPLC

作　　者：唐刚 金坚 杨子毅 TANG Gang;JIN Jian;YANG Ziyi(School of Pharmaceutical Science,Jiangnan University,Wuxi 214122,China)

机构地区：[1]江南大学药学院,无锡214122

出　　处：《中国药科大学学报》2020年第2期161-167,共7页Journal of China Pharmaceutical University

基　　金：国家自然科学基金资助项目(No.81603060)。

摘　　要：建立红花W/O型乳膏剂中羟基红花黄色素A含量测定的反相高效液相色谱法(RP-HPLC)。色谱柱为Zorbax Eclipse C18(4.6 mm×250 mm,5μm)色谱柱,流动相:甲醇-乙腈-0.02%磷酸水溶液(26∶2∶72),流速:1.0 mL/min,柱温:55℃,检测波长:403 nm。乳膏剂依次经甲醇高温破乳、纯水高温萃取后,采用RP-HPLC检测。结果显示,乳膏剂中辅料对羟基红花黄色素A色谱峰不产生干扰。羟基红花黄色素A在1.236~12.36μg/mL范围内呈良好的线性关系(y=156.17x+1.1983,r=0.9995),检测限为23.6 ng/mL,定量限为118 ng/mL,回收率在99.7%~103.3%范围内,精密度RSD为0.12%(n=6),室温放置24 h稳定性良好。本方法简便快捷,结果准确、重复性好,可用于红花W/O型乳膏剂中羟基红花黄色素A的含量测定。A reversed phase HPLC method for determination of hydroxylsafflower yellow A in safflower W/O cream was established.The column was Zorbax Eclipse C18 column(4.6 mm×250 mm,5μm),and the mobile phase was composed of methanol,acetonitrile and 0.02%phosphoric acid solution(26∶2∶72).The flow rate of mobile phase was set at 1.0 mL/min,and the column temperature was kept at 55°C.The detection wavelength was 403 nm.Safflower W/O cream was successively demulsified with methanol at high temperature and followed by the addition of purified water for the extraction.The results showed that the excipients did not interfere with the chromatographic peak of hydroxylsafflower yellow A.Hydroxylsafflower yellow A presented a good linear relationship in the range of 1.23612.36μg/mL(y=156.17x+1.1983,r=0.9995),and the detection limit was 23.6 ng/mL with the quantitative limit of 118 ng/mL.The percentage of extracting recovery was in the range of 99.7%to 103.3%.The precision RSD was 0.12%(n=6),and the sample stability was acceptable when being stored at room temperature for 24 h.The developed method in this study was simple,rapid,accurate and reproducible,and can be used for the determination of hydroxylsafflower yellow A in safflower W/O cream.

关 键 词：红花 W/O型乳膏剂 羟基红花黄色素 RP-HPLC 含量测定 

分 类 号：R917[医药卫生—药物分析学]