盐酸西替利嗪鼻腔喷雾剂质量标准研究

目的：建立盐酸西替利嗪喷雾剂的质量标准。方法：采用硅钨酸试液及分光光度法对盐酸西替利嗪喷雾剂进行定性鉴别并测定其每喷喷量,高效液相法（HPLC）测定喷雾剂中盐酸西替利嗪的含量。结果：盐酸西替利嗪喷雾剂滴加硅钨酸试液即产生白色沉淀,在230nm处有最大吸收,每喷喷量为100μl;盐酸西替利嗪在0.1～5mg/ml之间线性关系良好（y=12.336x＋0.197r=1.00）,加样回收率99.77%,RSD为0.92%（n=9）。结论：所建立的方法简便,可行,重现性好,可用于盐酸西替利嗪喷雾剂的质量控制。

Study on quality standard of Cetirizine Hydrochloride Nasal Spray

Objective：To establish the quality standard of Cetirizine Hydrochloride Nasal Spray.Methods：Cetirizine hydrochloride in the nasal spray was identified by silicotungstic acid solution and absorption spectrometry.The content of cetirizine hydrochloride was determined by HPLC.Results：The white precipitate emerged when silicotungstic acid solution was added into Cetirizine Hydroehloride Nasal Spray and cetirizine hydrochloride had maximum absorption in 230nm.The cetirizine hydrocbloride was tested well and the linear range was obtained in 0.1-5 mg/ml （y=12.336x＋0.197 r=1.00）.The average recovery rate was 99.77%,RSD为0.92%（n=9）.Conclusion： The method is convenient, reliable and accurate for the quality control of Cetirizine Hydrochloride Nasal Spray.