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目的:考察加替沙星滴眼液除菌过滤时不同材质滤膜对于苯扎氯铵的吸附性;建立高效液相色谱法测定加替沙星滴眼液中苯扎氯铵的含量。方法:采用材质为聚醚砜(PES)、聚偏二氟乙烯(PVDF)的滤膜过滤加替沙星滴眼液后,收集滤液,于100,500,1 000,1 500,2 000 mL时取样,测定过滤后苯扎氯铵的含量;以水(用1 mol·L-1高氯酸调pH至2.2±0.05)-乙腈-异丙醇(58∶33∶9)为流动相等度洗脱;流速1.0mL·min-1;柱温40℃;检测波长214 nm。结果:材质为聚偏二氟乙烯(PVDF)的滤膜对于苯扎氯铵有6.3%的吸附,而材质聚醚砜(PES)对于苯扎氯铵无吸附性;苯扎氯铵在11.1~111μg·mL-1(222~2 220ng)浓度范围内呈良好的线性,线性方程为y=22 162x-15 620(r=0.999 9),平均回收率为100.58%、RSD=0.60%(n=9),准确度较好。结论:对于加替沙星滴眼液的生产,采用材质为聚醚砜(PES)的滤膜对其中抑菌剂苯扎氯铵无吸附;建立了HPLC法测定加替沙星滴眼液中苯扎氯铵的方法,操作简便,灵敏度高,重复性好,可快速准确用于加替沙星滴眼液中苯扎氯铵含量分析。
OBJECTIVE: To investigate the adsorption of benzalkonium chloride on different membrane filters when gatifloxacin eye drops were sterilized and to establish a HPLC method for the determination of benzalkonium chloride in gatifloxacin eye drops. Methods: Gatifloxacin eye drops were filtered with polyethersulfone (PES) and polyvinylidene difluoride (PVDF) filters. The filtrates were collected and sampled at 100, 500, 1000, 1 500 and 2 000 mL , And the content of benzalkonium chloride after filtration was measured. The mobile phase consisted of water (adjusted to pH 2.2 ± 0.05 with 1 mol·L-1 perchloric acid) -acetonitrile-isopropanol (58:33:9) ; Flow rate 1.0mL · min-1; column temperature 40 ℃; detection wavelength 214 nm. Results: The filter made of polyvinylidene difluoride (PVDF) had 6.3% adsorption on benzalkonium chloride, while the material PES had no adsorption on benzalkonium chloride; The linear equation was y = 22 162x-15 620 (r = 0.999 9) with the average recovery of 100.58% and RSD = 0.60% (n = 9), the accuracy is better. Conclusion: For the production of gatifloxacin eye drops, the antibacterial agent benzalkonium chloride was not adsorbed on the membrane of polyethersulfone (PES). The HPLC method was established for the determination of gatifloxacin eye drops Benzalkonium chloride method, simple, high sensitivity, good repeatability, can be quickly and accurately used for determination of benzalkonium chloride in gatifloxacin eye drops.