氟尿嘧啶注射液含量测定方法的建立

Establishment of Determination Method for Fluorouracil Injection

目的:建立氟尿嘧啶注射液含量测定的HPLC方法。方法:采用十八烷基硅烷键合硅胶色谱柱(亲水性色谱柱),6.8 g·L^(-1)磷酸二氢钾溶液用5 mol·L^(-1)氢氧化钾溶液调节pH至5.7为流动相,检测波长254 nm,以氟尿嘧啶为对照品,按外标法计算。结果:该方法在氟尿嘧啶0.03~12.06μg·mL^(-1)范围内线性关系好,相关系数r=0.9999(n=5);加样回收率为100.6%,RSD=0.4%(n=9);仪器精密度高,多次进样RSD=0.1%(n=6)。供试品溶液在12 h内稳定,且辅料不干扰。结论:本方法快速灵敏、准确度高、专属性强,可以作为氟尿嘧啶注射液质量控制中含量测定的可靠方法。

Objective To establish an HPLC method to determine the content of fluorouracil injection.Methods Octadecylsilane bonded silica gel column(hydrophilic column)was used and the mobile phase was potassium dihydrogen phosphate solution(6.8 g·L^(-1))with pH 5.7.The detection wavelength was 254 nm.Fluorouracil was used as the reference substance and calculated according to the external standard method.Results The method had a good linear relationship in the range of 0.03~12.06μg·mL^(-1)fluorouracil,and the correlation coefficient was r=0.9999(n=5).The recovery rate was 100.6%,RSD=0.4%(n=9).The precision of the instrument was high,RSD=0.1%(n=6).The test solution was stable within 12 hours without interference of excipients.Conclusion The method is fast,sensitive,accurate and specific,and can be used as a reliable method for the content determination of fluorouracil injection in quality control.