高效液相色谱法测定溴芬酸钠水合物滴眼液中苯扎氯铵的含量

Determination of benzalkonium chloride in bromfenac sodium hydrate eye drops by HPLC

目的： 建立溴芬酸钠水合物滴眼液中防腐剂苯扎氯铵含量测定的高效液相色谱方法。 方法： 采用BDS HYPERSIL Cyano氰基键合硅胶色谱柱（150 mm×4.6 mm，5 μm），以0.1%磷酸溶液-乙腈-四氢呋喃（51：39：10）为流动相，流速1.0 mL·min^-1，检测波长214 nm，柱温30 ℃。 结果： 苯扎氯铵浓度在0.9904-19.81 μg·mL^-1范围内与峰面积呈良好线性关系（r=0.9999），低、中、高浓度回收率分别为99.7%、99.7%、100.2%，RSD分别为0.5%、0.5%、0.9%。 结论： 经过方法学验证，本法可用于溴芬酸钠水合物滴眼液中防腐剂苯扎氯铵的含量测定。

Objective： To determine the content of benzalkonium chloride in bromfenac sodium hydrate eye drops by HPLC. Methods： Chromatography was performed on a BDS HYPERSIL Cyano（150 mm×4.6 mm,5 μm）column.The mobile phase consisted of 0.1% phosphoric acid-acetonitrile-tetrahydrofuran（51： 39： 10）at the flow rate of 1.0 mL·min^-1.The detection wavelength was 214 nm,and the column temperature was 30 ℃. Results： The linear response range was 0.9904-19.81 μg·mL^-1 （r=0.9999）for the concentration of benzalkonium chloride and the peak area.The recovery of benzalkonium chloride was 99.7%,99.7% and 100.2% for low,middle and high concentrations respectively and RSDS were 0.5%,0.5% and 0.9%,respectively. Conclusion： The method is validated and can be used for assay of benzalkonium chloride in bromfenac sodium hydrate eye drops.