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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,5μm),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0.9904~19.81μg·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 establish a HPLC method for the determination of benzalkonium chloride in preservative benzbrobromide in bromfenac sodium hydrate eye drops. Methods: Cyclodextrins of BDS HYPERSIL Cyano bonded silica column (150 mm × 4.6 mm, 5 μm) with 0.1% phosphoric acid solution-acetonitrile-tetrahydrofuran , Detection wavelength 214 nm, column temperature 30 ℃. Results: The linear range of benzalkonium chloride concentration was 0.9904 ~ 19.81 μg · mL-1 (r = 0.9999), and the recovery rates were 99.7%, 99.7% and 100.2%, respectively. RSD were 0.5%, 0.5%, 0.9%. Conclusion: This method can be used to determine the content of benzalkonium chloride as preservative in bromfenac sodium hydrate eye drops.