右旋糖酐70甘油滴眼液中苯扎氯铵含量测定方法研究

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1.28~3.00 μg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.