摘要
目的 同时测定梓葛冻干粉针中梓醇和葛根素含量并考察其有关物质，为梓葛冻干粉针质量标准的制定提供参考。方法 采用RP-HPLC，色谱条件如下，色谱柱：Agilent Zorbax SB-C18 (4.6 mm ×250 mm， 5 μm)， 流动相：水（A）-乙腈（B），梯度洗脱，检测波长：210 nm，流速：1.0 mL·min-1。结果 该色谱条件下，空白辅料对主药测定无干扰，药物峰与各有关物质峰分离良好。梓醇和葛根素均在5～200 mg·L-1内线性关系良好，平均加样回收率分别为100.45%和98.17%，精密度、重复性RSD均小于2%。结论 本方法专属性强，准确、灵敏、简单，可用于梓葛冻干粉针剂的含量测定和有关物质的检查。
Abstract
OBJECTIVE To establish a method for simultaneous determination of the contents of catalpol and puerarin and their related substances in Zige freeze-dried powder for injection. METHODS The separation was carried out on a Agilent Zorbax SB-C18 column (4.6 mm ×250 mm， 5 μm) with gradient elution. The mobile phase consisted of water (A) and acetonitrile (B). The flow rate was 1.0 mL·min-1 and the detection wavelength was 210 nm. RESULTS The excipients did not interfere with the determination， and the peaks of the drug substances were separated well with their related substances. Both standard curves of catalpol and puerarin were linear in the range of 5-200 mg·L-1. The average recoveries of catalpol and puerarin were 100.45% and 98.17%， respectively. The RSDs of precision and repeatability were both less than 2%. CONCLUSION This method is specific， accurate， sensitive and simple. It can be used for the determination of catalpol and puerarin and their related substances in Zige freeze-dried powder for injection.
关键词
梓醇 /
葛根素 /
高效液相色谱法 /
含量 /
有关物质
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Key words
catalpol /
puerarin /
HPLC /
content /
related substances
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原欢欢 张继芬 王琴 徐晓玉.
RP-HPLC测定梓葛冻干粉针中的药物含量及有关物质[J]. 中国药学杂志, 2011, 46(16): 1276-1279
YUN Hun-hun;ZHNG Ji-fen;WNG Qin;XU Xio-yu.
Determination of Catalpol and Puerarin Contents and Their Related Substances in Zige Freeze-Dried Powder for Injection by RP-HPLC[J]. Chinese Pharmaceutical Journal, 2011, 46(16): 1276-1279
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参考文献
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脚注
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