HPLC测定氯化钠滴眼液中乙二胺四乙酸二钠的含量

Determination of Edetate Disodium in Sodium Chloride Eye Drops by HPLC

目的建立HPLCN定氯化钠滴眼液中依地酸二钠含量的方法。方法以十八烷基硅烷键合硅胶为填充剂；四丁基氢氧化铵磷酸盐缓冲液（取55％-60％四丁基氢氧化铵水溶液2．8mL，加水195mL，用磷酸调节pH值至3．0，加水至800mL）-乙腈（80：20）为流动相A，乙腈为流动相B，线性梯度洗脱：流速1．0mL／min；检测波长240nm。结果依地酸二钠在10-30μg／mL范围内呈良好的线性关系（r=0．9990）；平均回收率为101．0％（n=9，RSD=0．7％）。结论HPLC方法简便灵敏准确，重复性好，可用于氯化钠滴眼液中依地酸二钠的含量测定。

Objective To determine the content of edetate disodium in Sodium Chloride Eye Drops by HPLC. Methods A C18 column was used with gradient elution. Tetrabutylammonium hydroxide phosphate buffer solution （2.8 mL of 55 %-60 % tetrabutylammonium hydroxide aqueous solution mixed with 195 mL of water, adjusting pH to 3.0 with phosphoric acid, then diluted to 800 mL with water）- acetonitrile （80：20） was used as mobile phase A, acetonitrile was used as mobile phase B. The flow rate was 1.0 mL/min. The detection wavelength was 240 nm. Results The calibration curve was linear in the range of 10-30 μg/mL for edetate disodium （r=0.9990）. The average recovery was 101.0 % （n=9, RSD=0.7 %） for edetate disodium. Conclusion This method is simple, sensitive and accurate with a good repeatability, and can be used for the determination of edetate disodium in Sodium Chloride Eye Drops.