摘要
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 study the adsorption of benzalkonium chloride in the gatifloxacin ophthalmic solution through filters made of different materials,establish an HPLC method for the determination of benzalkonium chloride content in the gatifloxacin ophthalmic solution.METHODS The filtrate was collected after gatifloxacin ophthalmic solution was filtered through the membrane made of polyether sulfone（PES）and polyvinylidene fluoride（PVDF）.The samples collected when the volume reached 100,500,1 000,1 500 and 2 000 mL to determine and compare the contents of benzalkonium chloride.The chromatographic conditions were as follows：the mobile phase consisted of water（pH was adjusted to 2.2±0.05 with 1 mol·L^（-1） perchloric acid）-acetonitrile-isopropyl alcohol（58∶33∶9）.The flow rate was 1.0mL·min^（-1）,the column temperature was 40 ℃and the detection wave length was 214 nm.RESULTS 6.3% absorption was seen from the filter made of polyvinylidene fluoride（PVDF）after gatifloxacin ophthalmic solution was filtered,but none was observed for polyether sulfone（PES）to benzalkonium chloride.The calibration curve of benzalkonium chloride ranged from11.1–111μg·mL^（-1）（222-2 220 ng）had good linearity with peak area.The equation was y=22 162x-15 620（r=0.999 9）.The average recovery was 100.58%.RSD=0.60%（n=9）.CONCLUSION The filter made of polyether sulfone（PES）shows no adsorption to benzalkonium chloride,better for gatifloxacin ophthalmic solution.The HPLC method is established for determining benzalkonium chloride in the gatifloxacin ophthalmic solution.The method can be used to analyze benzalkonium chloride for its simple operation,high sensitivity and good reproducibility.
出处
《中国医院药学杂志》
CAS
北大核心
2017年第14期1379-1382,共4页
Chinese Journal of Hospital Pharmacy
关键词
苯扎氯铵
吸附
加替沙星滴眼液
benzalkonium chloride
adsorption
gatifloxacin ophthalmic solution
