摘要
目的建立测定5一氟尿嘧啶复乳原位凝胶中5一氟尿嘧啶含量的高效液相色谱法。方法采用Hypersil—C18柱（150inm×4．6mm。5μm），以水（用0．05mol／L磷酸溶液调节pH至3．5-甲醇（95：5）为流动相，流速为1．0mL／min，检测波长为266nm,柱温为25℃，进样量为20μL。结果3批样品中5-氟尿嘧啶的平均含量为99．26％，在0．6—18μg／mL质量浓度范围内与峰面积线性关系良好（r=0．9991），平均回收率为100．23％，RSD为1．97％（n=6）。结论该检测方法灵敏、快速、结果准确，适用于5-氟尿嘧啶复乳原位凝胶的质量控制。
Objective To establish a high performance liquid chromatography（HPLC） method for the determination of 5- fluorouraeil content in 5-Fluorouracil Multiple Emulsion In Situ Gel. Methods The Hypersil-C18 column（150 mm ×4.6 mm,5 μm） was used as the chromatography column with water（adjusting pH to 3.5 with 0.05 mol/L phosphoric acid solution）-methanol （95：5） as the mo- bile phase. The flow rate was 1.0 mL/min,the detective wavelength was 266 nm,the column temperature was 25 ℃ and the sample size was 20 μL. Results The average content of 5- fluorouracil in three batches of sample was 99.26%. 5- fluorouracil in the con- centration range of 0.6-18 p,g/mL showed good linear relation with the peak area（r=0.999 1）.The average recovery rate was 100. 23%, RSD was 1.97% （n = 6）. Conclusion The method is sensitive, rapid, accurate, which is suitable for the quality control of 5- Fluorouracil Multiple Emulsion In Situ Gel.
出处
《中国药业》
CAS
2014年第22期53-55,共3页
China Pharmaceuticals
