HPLC法同时测定清开灵注射液中黄芩苷和千层纸素A-7-O-β-d-葡糖醛酸苷的含量  

Simultaneous Content Determination of Baicalin and Oroxylin A-7-O-β-d-glucuronide in Qingkailing Injections by HPLC

作　　者：沈蒙[1] 段天璇[1] 孙毅坤[1] 黄建梅[1] 马长华[1] 

机构地区：[1]北京中医药大学中药学院,北京100102

出　　处：《中国药房》2014年第8期757-759,共3页China Pharmacy

摘　　要：目的：建立同时测定清开灵注射液中黄芩苷和千层纸素A-7-O-β-d-葡糖醛酸苷含量的方法，并比较不同厂家、批号产品中黄芩苷和千层纸素A-7-O-β-d-葡糖醛酸苷的含量差异。方法：采用高效液相色谱法。色谱柱为Agilent ZORBAX SB-C18，流动相为甲醇-0．1％磷酸溶液（梯度洗脱），流速为1．0ml／min，检测波长为274nm，柱温为30℃，进样量为10ul。结果：黄芩苷、千层纸素A-7-O-β-d-葡糖醛酸苷检测质量浓度分别在10．1-252．0、1．0～6．0ug／ml范围内与各自峰面积积分值呈良好的线性关系（r=0．9999）；精密度、稳定性、重复性试验的RSD≤1．6％；平均加样回收率分别为99．64％、99．03％，RSD分别为2．7％、0．9％（n=6）。不同厂家、批号产品中黄芩苷、千层纸素A-7-O-β-d-葡糖醛酸苷的质量浓度范围分别为4．151～4．849、0．097-0．157mg／ml。结论：该方法简单、准确、可靠，适用于清开灵注射液的质量控制；不同厂家、批号清开灵注射液中黄芩苷和千层纸素A-7-O-β-d-葡糖醛酸苷的含量存在较大差异。OBJECTIVE： To establish the method for simultaneous determination of baicalin and oroxylin A-7-O-β-d-glucuronide in Qingkailing injections, and to compare the content difference of samples from different manufacturers and different batches. METHODS： HPLC method was adopted. Agilent ZORBAX SB-C18, was used with mobile phase consisted of methanol-0.1% phosphoric acid （gradient elution） at the flow rate of 1.0 ml/min. The detection wavelength was set at 274 nm, and column temperature was 30 ℃. The injection volume was 10 ul. RESULTS： The linear range were 10.1-252.0 ug/ml for baicalin （r=0.999 9） and 1.0-6.0 ug/ml for oroxylin A-7-O-β-d-glucuronide （r=0.999 9）. RSDs of precision, stability and reproducibility tests were all lower than 1.6%. The average recoveries of them were 99.64% and 99.03%, and RSDs were 2.7% and 0.9% respectively （n=6）. The concentration ranges of baicalin and oroxylin A-7-O-β-d-glucuronide in Qingkailing injections from different manufacturers and different batches were 4.151-4.849 mg/ml and 0.097-0.157 mg/ml separately. CONCLUSIONS： The method is simple, accurate, rapid and suitable for quality control of Qingkailing injections. There are great difference on the contents of baicalin and oroxylin A-7-O-β-d-glucuronide in Qingkailing injections from different manufacturers and different batches.

关 键 词：高效液相色谱法 清开灵注射液 黄芩苷 千层纸素A-7-O-β-d-葡糖醛酸苷 

分 类 号：R917[医药卫生—药物分析学]