右旋糖酐70甘油滴眼液中苯扎氯铵含量测定方法研究

Determination of benzalkonium chloride in Dextran 70 and glycerol eye drops

目的:建立高效液相色谱法测定右旋糖酐70甘油滴眼液中苯扎氯铵的含量。方法:以氰基硅烷键合硅胶为填充剂;以乙腈-0.03 mol.L-1磷酸二氢钠溶液(用1 mol.L-1氢氧化钠溶液调pH至7.0)(43∶57)为流动相;流速:2.0 mL.min-1;柱温:35℃;检测波长214 nm。苯扎氯铵C12、C14、C16之间的分离度应符合规定。结果:苯扎氯铵在1.28～3.00μg范围内与峰面积线性关系良好(r=0.9999,n=7);平均回收率(n=6)为100.9%,RSD=0.9%。结论:该法操作简便,快速、准确,灵敏度高,重复性好,可用于右旋糖酐70甘油滴眼液中苯扎氯铵含量测定。

Objective：To determine the content of benzalkonium chloride in Dextran 70 and glycerol eye drops by HPLC.Methods：The chromatographic conditions were as follows：the column was Kromasil C18（250 mm×4.6 mm,5 μm）column;the mobile phase consisted of acetonitrile-0.03 mol·L-1 sodium dihydrogen phosphate（pH 7.0）（43∶ 57）;the flow rate was 2.0 mL·min-1;the column temperature was 35 ℃;the detection wavelength was at 214 nm;the injection volume was 20 μL;the separable degree of benzalkonium chloride between C12,C14,C16,should meet rules.Results：The calibration curve of benzalkonium chloride ranged from 1.28-3.00 μg had good linearity with peak area（r=0.9999,n=7）;The recovery（n=6）was 100.9%;RSD=0.9%.Conclusion：The method is simple,fast,and accurate,with high sensitivity and good repeatability,and can be used for content determination of benzalkonium chloride in Dextran 70 and glycerol eye drops.