Study on the Improving the Quality Standard for Compound Pediatric Anticough Oral Solution / 中国药房

ABSTRACT

OBJECTIVE:To optimize and improve the quality standard for Compound pediatric anticough oral solution. METH-ODSTLC was adopted for the qualitative identification of Glycyrrhiza uralensis;chemical reaction was adopted for the qualitative identification of ipecac tincture,ammonium chloride;and HPLC was adopted for the content determination of ammonium glycyrrhi-zinatethe column was Agilent Zorbax XDB C18 with mobile phase of acetonitrile-0.2 mol/L ammonium acetate(20∶80,V/V)at a flow rate of 1.0 ml/min,the detection wavelength was 250 nm,column temperature was 30℃,and the injection volume was 10 μl. RESULTS:TLC spots of G. uralensis were clear and well-separated,negative control without interference. Differential response of ipecac tincture and ammonium chloride showed significant positive characteristics. The linear range of ammonium glycyrrhizinate was 6.08-72.96 μg/ml (r=0.999 9);RSDs of precision,stability and reproducibility tests were lower than 1.0%;recovery was 99.69%-100.28%(RSD=0.20%,n=6). CONCLUSIONS:Optimizing and improving the standard are helpful for the quality con-trol of Compound pediatric anticough oral solution.