摘要
Abstract
Objective Establish ranitidine hydrochloride cleaning validation analysis method and sampling method.Methods Using HPLC method for testing, chromatographic column Kromasil C18 (4.6mm*150cm,5?m);Flow to buf er for buf ered salt and acetonitrile (90:10);Detection wavelength of 230 nm;The flow rate of 1.5 mL/min.Results Ranitidine hydrochloride reference substance solution including in 3.0 g/ml to including 60.0 g/ml,it represents to the preparation of 10% to 200% of the standard linear solution,has a good linear relationship,the square of the linear cor elation factor of 1.0000.And using the method of sampling, recovery rate can reach 90%.Conclusion This method is simple, sensitive and specific,can be used to ranitidine hydrochloride tablets cleaning validation drug residues detection.关键词
盐酸雷尼替丁胶囊/清洁验证/方法分析Key words
Ranitidine hydrochloride/Cleaning validation/Methods to analyze
