摘要
建立HPLC方法同时测定通便凝胶贴剂中白术内酯Ⅰ、藁本内酯含量。采用C_(18)色谱柱(250 mm×4.6 mm,5μm),流动相:乙腈∶水(78∶22),流速1.0 m L/min,柱温为30℃,检测波长275 nm,进样体积20μL。白术内酯Ⅰ、藁本内酯在相应的范围内与峰面积呈良好线性关系(r>0.9995);低、中、高3浓度水平9份样品的平均加样回收率分别为95.29%(RSD=2.88%)、99.19%(RSD=3.73%);仪器精密度良好,RSD依次为1.74%、1.77%;重复性好,RSD依次为1.81%、1.30%;稳定性试验符合要求,RSD依次为2.88%、2.87%;经测定,通便凝胶贴剂中白术内酯Ⅰ、藁本内酯含量为(47.07±0.61)、(988.14±6.17)μg/g。该方法简便可行准确,专属性和线性关系好,可用于通便凝胶贴剂的质量控制,并为其质量标准建立提供参考。
To establish a HPLC method for simultaneous determination of atractylenolide I and ligustilide in defecation gel patches,the C_(18) column(250 mm×4.6 mm,5μm)is used with a mobile phase of acetonitrile:water(78:22)at a flow rate of 1.0 mL/min,the column temperature is 30℃,the detection wavelength is 275 nm,and the injection volume is 20μL.The atractylenolide I and ligustilide shows a good linear relationship with the peak area in the corresponding range(r>0.9995).The average recoveries of 9 samples at low,medium and high concentration levels are 95.29%(RSD=2.88%)and 99.19%(RSD=3.73%),respectively.The precision is good,the RSD is 1.74%,1.77%successively.The repeatability is good,the RSD is 1.81%and 1.30%successively.The stability test meets the requirements,the RSD is 2.88%,2.87%,respectively.The contents of atractylenolide I and ligustilide in the defecation gel patches are(47.07±0.61)and(988.14±6.17)μg/g.The method is simple,feasible,accurate,specific and linear,which can be used for the quality control of defecation gel patches and provide reference for the establishment of quality standards.
作者
陈程
李伟泽
赵宁
杨洁
龚立文
CHEN Cheng;LI Weize;ZHAO Ning;YANG Jie;GONG Liwen(Pharmaceutical Institute,Xi’an Medical University,Xi’an 710021,China;Jiangsu Weina Pharmaceutical Technology Co.,Ltd.,Yangzhong 212218,China)
出处
《化学与粘合》
CAS
2024年第3期297-301,共5页
Chemistry and Adhesion
基金
2022年度陕西高校青年创新团队科研计划项目(编号:22JP075)
陕西省科技厅科技计划项目青年项目(编号:2023-JC-QN-0822)
陕西高校青年创新团队建设项目(编号:陕教[2019]90号)
西安医学院科技创新团队配套(编号:2021TDPT04)。
