目的 确定氟尿嘧啶注射液含量测定的最佳方法。方法 分别采用紫外吸收系数法和高效液相色谱法对95批氟尿嘧啶注射液的含量进行测定,通过对两种方法的回收率的考察,结合氟尿嘧啶双醇-双酮式结构及其注射液的生产工艺,分析引起含量测定结果差异的原因。结果 高效液相色谱法测定的结果略高于紫外吸收系数法,两种方法的测定结果有显著性差异(P<0.05)。氟尿嘧啶特有的双醇式结构和双酮式结构的互变,可能是导致紫外吸收系数法测定氟尿嘧啶回收率及含量偏低的原因之一。结论 通过比较认为,高效液相色谱法的定性、定量较紫外吸收系数法更加准确、可靠。
Abstract
OBJECTIVE To confirm the best content determination method of fluorouracil injection.METHODS The contents of 95 batches of fluorouracil injection were determined by UV spectrophotometry absorption coefficient method and high performance liquid chromatography (HPLC), respectively.Through investigation of method recoveries, the reasons for difference in the content determination results were further analyzed.RESULTS The HPLC determination results were slightly higher than those of the UV method (P<0.05), The intervonversion of double alcohol type structure and double ketone type structure of fluorouracil might lead to the lower recovery and determination results of UV method. CONCLUSION The HPLC method is more accurate and reliable than UV method qualitatively and quantitatively.
关键词
氟尿嘧啶注射液 /
紫外吸收系数法 /
高效液相色谱法 /
双醇式结构 /
双酮式结构
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Key words
fluorouracil injection /
UV spectrophotometry absorption coefficient method /
HPLC /
double alcohol type /
double ketone type structure
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中图分类号:
R917
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参考文献
[1] VAN L J, RUSTUM Y M, ACKLAND S P, et al. Comparison of 5-fluoro-2′-deoxyuridine with 5-fluorouracil and their role in the treatment of colorectal cancer. Eu J Cancer,1998,34(3):296-306.
[2] YE M,ZHU Z,FU Q, et al. Pharmacokinetic analysis on tissue penetration of tegafur and tumor-selective distribution of 5-FU in patients with advanced breast cancer . Chin Pharm J(中国药学杂志), 2007,42(1)48-52.
[3] Ch.P(2010)Vol Ⅱ(中国药典2010年版.二部) . 2010:395-396.
[4] USP 34-NF 29 . 2011.
[5] FENG W Y, CAI S, SHEN J W. Determination of 5-fluorouracil in human plasma by high performance liquid chromatography . Chin Pharm J (中国药学杂志), 2003,38(4)289-290.
[6] LI Z B. Theoretical studies on tautomers of 5-fluorouracil and 5-chlorouracil. Acta Chim Sin (化学学报), 2005, 63(16):1495-1499.
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脚注
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