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

Determination of benzalkonium chloride concentration in tobramycin in-situ forming eye gel by high performance liquid chromatography

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,5μm),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16.22～81.10μg/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 μm）,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 regression equation 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.