HPLC法测定氟康唑滴眼液中苯扎溴铵的含量

Determination of benzalkonium bromide in fluconazole eye drops by HPLC

目的建立HPLC法测定氟康唑滴眼液中苯扎溴铵的含量。方法色谱柱为C18（150 mm×4.6 mm,5μm）;流动相：0.015 mol.L-1辛烷磺酸钠及0.02 mol.L-1乙酸钠溶液（含0.05%三乙胺,用冰乙酸调节pH值至4.0±0.2）-甲醇-乙腈（25：15：60）;流速：1.0 m l.m in-1;检测波长：262 nm;进样量20μl。结果苯扎溴铵在17.98~359.6 mg.L-1浓度范围线性关系良好（r=0.9997）,最小检出量约为1.0 ng,平均回收率为100.45%,RSD为0.94%。结论本法简便,快速,准确,灵敏度高,重复性好,可用于氟康唑滴眼液中苯扎溴铵的含量测定。

Aim To develop an HPLC method for the determination of benzalkonium bromide in fluconazole eye drops.Method A C18 column（150 mm×4.6 mm,5 μm） was adopted with 0.015 mol·L-1 perfluorooctane sulfonate and 0.02 mol·L-1 sodium acetate solution（containing 0.05% triethylamine,and the pH value is adjusted to 4.0±0.2 by glacial acetic acid）-methanol-acetonitrile（25：15：60） as mobile phase.The flow rate was 1.0 ml·min-1,the detection wavelength was 262 nm and the injection volume was 20 μl.Results Within the range from 17.98 to 359.6 μg·ml-1,benzalkonium bromide presented a good relationship between the injected amounts and peak areas（r=0.9997）,with the detection limit of 1.0 ng.The average recovery was 100.45 %,with the RSD of 0.94 %.Conclusion The method is rapid,accurate,and reproducible.It can be used for the quality control of benzalkonium bromide in fluconazole eye drops.