氟尿嘧啶注射液含量测定方法的研究

Research of Determination Methods of Fluorouracil Injection

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。

OBJECTIVE To confirm the best content determination method of fluorouracil injection. METHODS The contentsof 95 batches of fluorouracil injection were determined by UV spectrophotometry absorption coefficient method and high performance liq- uid chromatography （ HPLC）, respectively. Through investigation of method recoveries, the reasons for difference in the content deter- mination 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 low- er recovery and determination results of UV method. CONCLUSION The HPLC method is more accurate and reliable than UV meth- od qualitatively and quantitatively.