HPLC法测定盐酸左西替利嗪搽剂中苯扎溴铵的含量

Determination of benzalkonium bromide in Levocetirizine Hydrochloride Liniment by HPLC

目的建立高效液相色谱法测定盐酸左西替利嗪搽剂中苯扎溴铵的含量。方法采用C18柱(4.6 mm×150 mm,5μm),以0.02 mol.L-1的庚烷磺酸钠溶液(含0.1%三乙胺,用磷酸调节至pH值至3.5)-乙腈(35∶65)为流动相,检测波长为262 nm,柱温为30℃,流速为1.0 mL.min-1。结果盐酸左西替利嗪搽剂中苯扎溴铵浓度在10.3～206.0μg.mL-1浓度范围内线性关系良好(r=0.999 9),最小检出量约为1.2 ng,平均回收率为100.13%,RSD为0.52%。结论本方法简便,快速,准确,灵敏度高,重复性好,可用于盐酸左西替利嗪搽剂中苯扎溴铵含量的测定。

Objective To establish an HPLC for the determination of benzalkonium bromide in Levocetirizine Hydrochloride Liniment. Methods C18 column（4.6 mm× 150 mm,5 μm）was used,and the mobile phase consisted of 0.02 mol . L^-1 sodium heptanesulfonate （ containing 0.1% triethylamine and the pH value was adjusted to 3.5 by phosphoric acid/ -acetonitrile（35：65 ） ,the detection wavelength was 262 nm,the column temperature was 30 ℃ and the flow rate was 1.0 mL·min^-1. Results The linear range of benzalkonium bromide was 10.3 - 206.0 μg·mL^-1 （ r = 0. 999 9 ） , and the minimum detectable amount was 1.2 ng. The average recovery was 100.13% ,with the RSD of 0.52%. Conclusion The method was rapid, accurate and reproducible. It can be used for the quality control of benzalkonium bromide in Levocetirizine Hydroehloride Liniment.