高效液相色谱法测定盐酸羟苄唑滴眼液中苯扎溴铵含量

摘要

Objective To establish a high performance liquid chromatograph ( HPLC ) method for determining the content of benzalkonium bromide in Hydrobenzole Hydrochloride Eye Drops. Methods The Hypersil ODS C18 column(250 mm × 4. 6 mm,5 μm) was adopted with the mobile phase of 0. 07 mol/L ammonium acetate solution (containing 1% triethylamine and adjusting pH to 5. 0 by glacial acetic acid)-acetonitrile(35 :65),the flow rate was 1. 0 mL/min and the detection wavelength was 262 nm. Results The mass con-centration of benzalkonium bromide in the range of 13. 215-66. 075 μg/mL showed good linear relation with the peak area( r=0. 999 9, n=5). The limit of detection was 0. 7 μg/mL. The average recovery rate was 99. 35%,RSD=0. 57%( n=9). Conclusion The estab-lished method is simple and accurate with good precision,which is used for the contents determination of benzalkonium bromide in Hy-drobenzole Hydrochloride Eye Drops.%目的：建立测定盐酸羟苄唑滴眼液中苯扎溴铵含量的高效液相色谱法。方法色谱柱为Hypersil ODS C18柱（250 mm ×4.6 mm，5μm）；流动相为0.07 mol/L醋酸铵溶液（含三乙胺0.1%，用冰醋酸调节pH至5.0）-乙腈（35：65），流速为1.0 mL/min，检测波长为262 nm。结果盐酸羟苄唑滴眼液中苯扎溴铵质量浓度在13.215～66.075μg/mL范围内与峰面积呈良好线性关系（ r＝0.9999， n＝5），检测限为0.7μg/mL，平均回收率为99.35%，RSD＝0.57%（ n＝9）。结论该方法简便，准确，精密度好，可作为盐酸羟苄唑滴眼液中苯扎溴铵的含量测定方法。