摘要
目的:建立双波长HPLC法测定康乐鼻炎片中穿心莲内酯和脱水穿心莲内酯的含量。方法:采用Kromasil C_(18)(4.6 mm×250 mm,5μm)色谱柱,以甲醇-水(46∶54)作为流动相,流速0.7 mL·min^(-1),柱温35℃,穿心莲内酯检测波长为225 nm,脱水穿心莲内酯检测波长为254 nm。结果:穿心莲内酯、脱水穿心莲内酯分别在0.005~0.549μg(r=0.9999)、0.006~0.560μg(r=0.9999)范围内,线性关系良好;平均回收率分别为99.03%(RSD为0.5%)、99.03%(RSD为0.6%)。结论:该方法操作简单、专属性强、重复性好,可作为康乐鼻炎片中穿心莲的质量控制。
Objective:To establish an HPLC with dual-wavelength detection for the determination of andrographolide and dehyandrographolide in Kangle Biyan Tablets by HPLC.Methods:The determination was performed on Kromasil C_(18)(4.6mm×250 mm,5μm)under the isocratic elution of methanol and water(46∶54).The flow rate was 0.7 mL·min^(-1)and the column temperature was 35℃.The detection wavelengths of andrographolide and dehyandrographolide were 225 nm and 254 nm respectively.Results:The linear ranges of andrographolide and dehyandrographolide fell into 0.005-0.549μg(r=0.9999)and 0.006-0.560μg(r=0.9999)respectively.The average recoveries of andrographolide and dehyandrographolide were 99.03%with RSD as 0.5%(n=6)and99.03%with RSD as 0.6%(n=6)respectively.Conclusion:The established method was simple,specific,accurate and reliable,and has the good repeatability.It is suitable for the quality control of andrographis paniculata in Kangle Biyan Tablets.
作者
杨献玲
赵凯鑫
翟宏宇
王海洋
YANG Xianling;ZHAO Kaixin;ZHAI Hongyu;WANG Haiyang(Jilin Institute for Drug Control,Changchun 130033,China)
出处
《中国药品标准》
CAS
2022年第1期51-54,共4页
Drug Standards of China
关键词
高效液相色谱法
双波长法
康乐鼻炎片
穿心莲
穿心莲内酯
脱水穿心莲内酯
含量测定
HPLC
dual-wavelength detection
Kangle Biyan Tablets
Andrographis paniculata
andrographolide
dehyandrographolide
content determination