HPLC法同时测定苦木注射液中3种活性成分的含量  

HPLC simultaneous determination of three active ingredients in Kumu injection

作　　者：赖正权[1] 欧国灯[2] 肖树雄[2] 廖祝元 廖慧君[1] 秦臻[1] 林吉[1] 苏子仁[1] 

机构地区：[1]广州中医药大学,广州510006 [2]广东省药品检验所,广州510180 [3]江西青峰药业有限公司,赣州341000

出　　处：《药物分析杂志》2011年第1期15-18,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的：建立同时测定苦木注射液中3种活性成分3-甲基-铁屎米-2,6-二酮、4-甲氧基-5-羟基铁屎米酮、4,5-二甲氧基-铁屎米酮含量的分析方法。方法：采用高效液相色谱法,色谱柱为Phenom enex Gem in i C18（150 mm×4.6 mm,5μm）柱,流动相为pH 7.5的0.2 mol.L-1磷酸氢二钠及磷酸二氢钠缓冲液（A）？甲醇（B）,梯度洗脱,流速1 mL.m in-1,检测波长254 nm,柱温30℃。结果：苦木注射液中3-甲基-铁屎米-2,6-二酮、4-甲氧基-5-羟基铁屎米酮、4,5-二甲氧基-铁屎米酮线性范围分别为0.0380~0.7600μg（r=0.9999）,0.0450~0.9000μg（r=0.9999）,0.0287~0.574μg（r=0.9999）;平均加样回收率（n=9）分别为99.3%,101.4%,101.8%。结论：该方法操作简单,重复性好,为评价和监控苦木注射液的质量提供可靠的方法。Objective：To establish a method for simultaneous determination of three active ingredients：3-methylcanthin-2,6-dione,4-methoxy-5-hydroxycanthin-6-one,4,5-dimethoxycanthin-6-one in Kumu injection.Methods：The determination was carried out with Phenomenex Gemini C18 column（150 mm×4.6 mm,5 μm）;The mobile phase consisted of 0.2 mol·L-1,pH 7.5 phosphate buffer（A）-methanol（B） with gradient elution at a flow rate of 1.0 mL·min-1;The detection wavelength was 254 nm,and the column temperature was 30 ℃.Results：The calibration curves were linear in the ranges of 0.0380-0.7600 μg for 3-methylcanthin-2,6-dione（r=0.9999）,0.0450-0.9000 μg for 4-methoxy-5-hydroxycanthin-6-one（r=0.9999） and 0.0287-0.574 μg for 4,5-dimethoxycanthin-6-one（r=0.9999）.The average recoveries（n=9） were 99.3%,101.4%,and 101.8%,respectively.Conclusion：The method is simple and repeatable,which can be applied to the quality control of the Kumu injection.

关 键 词：苦木注射液 3-甲基-铁屎米-2 6-二酮 4-甲氧基-5-羟基铁屎米酮 4 5-二甲氧基-铁屎米酮 高效液相色谱法 含量测定 

分 类 号：R917[医药卫生—药物分析学]