高效液相色谱法测定盐酸地匹福林眼用凝胶剂的含量

HPLC Determination of Dipivefrin Hydrochloride in the Ophthalmic Gel

目的 :测定盐酸地匹福林 (DPE)眼用凝胶剂的含量。方法 :在ODS -C1 8色谱柱上采用流动相甲醇 - 0 0 2mol·L- 1 磷酸二氢钾溶液 (80∶2 0 ) ,波长 2 2 0nm进行检测。结果 :在 10 0～ 10 0 0 μg·mL- 1 范围内 ,DPE对照品的峰面积 (Y)与其浓度 (X)呈现良好的线性关系 ,r=0 9999,最低检测限 40ng·mL- 1 ,高、中、低 3种浓度平均回收率为 98 40 %～ 10 0 5 %(n =5 ) ,RSD分别为 1 17% ,1 15 % ,0 6 6 % ,平均日内、日间RSD分别为 0 70 % (n =6 )和 0 89% (n =5 )。结论 :本法快速、灵敏、准确、专属性高。

Objective:To determine the content of dipivefrin hydrochloride in the ophthalmic gel-samble by HPLC.Methods:A reversed-phase high performance liquid chromatographic method was developed.Dipivefrin hydrochloride was chromatographed on ODS-C 18 column,and detected at 220 nm.The mobile phase was methanol-0.02 mol·L -1 potassium dihydrogen phosphate solution (80∶20).Results:A good liner relationship was found between peak area and the concentration of dipivefrin hydrochloride over the range of 10.0～100.0 μg·mL -1.The average recovery of dipivefrin hydrochloride was 98.40%～100.5% (n=5),and RSD was 0.99%.The RSD between-day and within-day were 0.70% (n=6) and 1.22% (n=5) respectively.Conclusion:The method is simple,fast and accurate for analysis of dipivefrin hydrochloride.