RP-HPLC法测定加替沙星眼用凝胶剂含量

摘要

目的：建立测定加替沙星眼用凝胶剂含量的方法。方法采用 RP‐HPLC 法，色谱柱Diamonsil C18（250 mm ×4.6 mm ，5μm），流动相为乙腈‐0.3％磷酸溶液（pH 3）（23∶77），流速1.0 ml／min ，检测波长290 nm。结果标准曲线线性范围4.0～40.0μg／ml ，r＝0.9998；回收率为99.5％，RSD＝1.23％；精密度RSD＝2.54％。结论该法简便、快速、可靠，完全适合加替沙星眼用凝胶剂质量控制。%Objective To establish the method for the determination of gatifloxacin in eye gel . Methods The condition of RP‐HPLC was Diamonsil C18 column (250 mm × 4.6 mm ,5 μm) ,mobile phase of acetonitrile‐0.3%phspphoric acid solution adjusted to pH 3 with triethylamine(23∶77) and UV detector at 290 nm . Results The method proved to be linear in the range at 4.0~40.0 μg/ml of gatifloxain with correlation coefficient of 0.9998 . The average recovery and recision were 99.5% ,RSD=1.23% .The precision RSD=2.54% (n=6) . Conclusion The method is simple ,accurate ,specific and can be used to the quality control of the preparation .