HPLC法测定吡嘧司特钾滴眼液中苯扎溴铵和苯扎氯铵的含量

Determination of Benzalkonium Bromide and Benzalkonium Chloride in Pemirolast Potassium Eye Drops by HPLC

目的建立HPLC法测定吡嘧司特钾滴眼液中苯扎溴铵和苯扎氯铵的含量。方法色谱柱:C18(4.6mm×150mm,5μm);流动相:0.02mol.L-1庚烷磺酸钠溶液(含0.1%三乙胺,用磷酸调节pH为3.45±0.1)-乙腈(35∶65);检测波长:210nm;柱温:40℃。结果苯扎溴铵在49.86～997.2ng范围内线性关系良好(r=0.9999),最小检出量为0.15ng,平均回收率为97.4%,RSD为1.0%;苯扎氯铵在9.912～24.78ng范围内呈良好的线性关系(r=0.9999),最小检出量为0.85ng,平均回收率为99.9%,RSD为1.0%。结论本方法简便、快速、准确、灵敏度高、重复性好,可用于吡嘧司特钾滴眼液中苯扎溴铵和苯扎氯铵的含量测定。

Objective To develop an HPLC method for the determination of benzalkonium bromide and benzalkonium chloride in Pemirolast Potassium Eye Drops. Methods A C18 column （150 mm×150mm,5μm） was adopted with 0.02 mol·L^-1 sodium heptanesulfonate （containing 0.1% triethylamine, and the pH value was adjusted to 3.45±0.1 by phosphoric acid） -acetonitrile （35： 65） as the mobile phase. The detection wavelength was 210 nm. Results Within the range from 49.86 ng to 997.2 ng （r=0. 9999）, benzalkonium bromide presented a good relationship between the injected amounts and peak areas, with the minimum detectable amount of 0.15 ng. The average recovery was 97.4%, with the RSD of 1.0%. Within the range from 9. 912 ng to 24.78 ng （r=0. 9999）, benzalkonium chloride presented a good relationship between the injected amounts and peak areas, with the minimum detectable amount of 0.85 ng. The average recovery was 99.9%, with the RSD of 1.0%. Conclusion The method is simple, rapid, accurate, sensitive and reproducible. It can be used for the contents determination of benzalkonium bromide and benzalkonium chloride in Pemirolast Potassium Eye Drops.