HPLC法测定玻璃酸钠滴眼液中的葡萄糖酸氯己定含量

目的:研究玻璃酸钠滴眼液中的抑菌剂葡萄糖酸氯己定的含量测定方法。方法:用C18柱,磷酸盐溶液(取磷酸二氢钠0.7 g和高氯酸钠12.2 g,加水适量使溶解,加10%磷酸溶液3 ml,加水至1 000 ml,混匀)-乙腈(60∶40)为流动相;流速1.0ml.min-1;柱温40℃;检测波长:254 nm;进样量:20μl;采用外标法计算。结果:葡萄糖酸氯己定浓度在1.005～3.015μg.ml-1范围内与峰面积呈现良好的线性关系(r=0.999 7);平均回收率为100.8%(RSD=0.7%)。结论:所用方法操作简便、准确可靠,可用于玻璃酸钠滴眼液中葡萄糖酸氯己定的含量测定。

Content Determination of Chlorhexidine Gluconate in Sodium Hyaluronate Eye Drops by HPLC

Objective： To establish an HPLC method for the determination of chlorhexidine giuconate in sodium hyaluronate eye drops. Method： A Kromasil C18 column was used with phosphate solution （dissolving 0.7 g sodium dihydrogen phosphate and 12.2 g sodium perchlorate in water, adding 3 ml 10% phosphoric acid solution and diluting to 1 000 ml with water to obtain uniform mixture） - acetonitrile （60： 40）as the mobile phase at a flow rate of 1.0 ml ·min-1 The temperature of the column was 40℃, and the detection wavelength was 254 rim. The external standard method was applied to calculate the results. Result： The linear range of chlorhexidine gluconate was 1. 005-5. 015 μg ·ml- 1（r = 0.999 7）. The average recovery of chlorhexidine gluconate was 100.8% （RSD= 0.7% ）. Conclusion： The method is simple and accurate, and suitable for the quality control of chlorhexidine gluconate in sodium hyaluronate eye drops.