高效液相法测定盐酸氮卓斯汀鼻喷剂的含量

目的：建立测定盐酸氮卓斯汀鼻喷剂中盐酸氮卓斯汀含量的高效液相色谱方法。方法：色谱柱：Diamonsil C_（18）柱（250 mm×4.6 mm,5μm）;流动相：4%三乙胺（用醋酸调节pH至6.0）-乙腈-甲醇（45：21：34）;检测波长：289 nm;流速：1.0ml·min~（-1）;柱温：30℃。结果：盐酸氮卓斯汀在80~800μg·ml~（-1）范围内呈良好的线性关系（r=1.000 0）,平均加样回收率为99.93%,RSD=0.82%（n=9）。结论：本方法操作简便,灵敏,结果准确可靠,可用于盐酸氮卓斯汀鼻喷剂的质量控制。

Determination of Azelastine Hydrochloride Nasal Sprays by HPLC

Objective： To establish a content determination method for azelastine hydrochloride nasal sprays by HPLC. Method： The analytical column was a Diamonsil Cl8 （250 mm x 4.6 mm, 5 txm） column. The mobile phase was 4% triethylamine （adjusting pH to 6.0 with acetic acid）-acetonitrile-methanol （45：21：34 ） , the flow rate was 1.0 ml min- 1 , the detection wavelength was 289nm and the column temperature was maintained at 30~C. Result： The calibration curve showed good linear relationship within the range of 80-800 p,g ~ ml-1 （ r = 1. 000 0） , the average recovery was 99.93% and RSD was 0.82% （ n = 9）. Conclusion ： The method is sim- ple, fast and accurate, and can be used as the quality control method for the product.