高效液相色谱法测定妥布霉素眼用即用型凝胶中苯扎氯铵的含量

摘要

目的:建立高效液相色谱(HPLC)法测定妥布霉素眼用即用型凝胶中苯扎氯铵的含量.方法:HPLC法色谱柱为Kromasil C18(250.0 mm×4.6 mm,5 μm),0.07 mol/L乙酸铵溶液(含1%三乙胺,冰乙酸调节pH值至5.0)-乙腈(70:30)为流动相;检测波长215 nm,柱温35 ℃,流速0.8 ml/min.结果:苯扎氯铵在16.22～81.10 μg/ml范围内呈良好的线性关系(r=0.999 8,n=5),回归方程为Y ∧=6 091.9X+10 114,平均回收率为99.85%,RSD为1.07%.结论:该法简便、灵敏、准确、重复性好,可用于妥布霉素眼用即用型凝胶中的苯扎氯铵的含量控制.%Objective: To establish a high performance liquid chromatography ( HPLC ) method for the determination of benzalkonium chloride in tobramycin in-situ forming eye gel. Methods:HPLC,the chromatographic column was Kromasil C18(250. 0 mm ×4. 6 mm, 5 (j,m) ,the mobile phase 0.07 mol/L ammonium acetate solution(including 1% triethylamine,adjusting with glacial acetic acid to pH 5. 0) -acetonitrile(70: 30). The detection wavelength 215 nm,the column temperature 35 ℃ ,the flow rate was 0. 8 ml/min. Results: The calibration curve was linear in the range of 16. 22 —81. 10 μg/ml for benzalkonium chloride ( r = 0. 999 8, n = 5 ) , the regressionrnequation was Y =6 091. 9X + 10 114,the average recovery was 99. 85% ,RSD was 1. 07%. Conclusions: The method is convenient, sensitive and accurate with a good repeatability for the determination of benzalkonium chloride in tobramycin in-situ forming eye gel.