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  

Determination of andrographolide and dehyandrographolide in Kangle Biyan Tablets by HPLC with dual-wavelength detection

作　　者：杨献玲[1] 赵凯鑫 翟宏宇[1] 王海洋[1] YANG Xianling;ZHAO Kaixin;ZHAI Hongyu;WANG Haiyang(Jilin Institute for Drug Control,Changchun 130033,China)

机构地区：[1]吉林省药品检验所,长春130033

出　　处：《中国药品标准》2022年第1期51-54,共4页Drug Standards of China

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.

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 

分 类 号：R921.2[医药卫生—药学]