一种盐酸左氧氟沙星片溶出度测定方法

A Determination for the Dissolution of Levofloxacin Hydrochloride Tablets

目的:对盐酸左氧氟沙星片溶出度方法进行方法学验证,同时确定方法。参照《中国药典》2015版方法:分别以UHPLC、UV两种方法测定盐酸左氧氟沙星片溶出度,并分别进行方法学验证。考察包括线性、精密度、稳定性、重复性、回收率试验等。根据两种方法的方法学验证可知,UHPLC和UV法均能准确测定本品含量,专属性高。结论:综合考虑,拟定以UHPLC法作为本品溶出度测定的方法。

Make sure of Detection method from determination for the dissolution of Levofloxacin Hydrochloride Tablets. Refer to 《 The Chinese pharmacopoeia》（2015 edition）, use UHPLC and UV to measure the dissolution and processed methodology validation.）. Contains linearity, precision, stability, repeatability, recovery test.The test result shows that both of two methods can measure the test accurately. Conclusion： use UHPLC to measure the determination for the dissolution of Levofloxacin Hydrochloride.