【摘要】 目的建立复方罗红霉素片中罗红霉素和盐酸氨溴索的溶出度的HPLC法。方法以醋酸盐缓冲液(pH 5.5)900mL为溶出介质,转速为100r.min-1,用高效液相色谱法测定,检测波长为210nm。结果罗红霉素和盐酸氨溴索分别在(83.5～250.5)μg.mL-1和(16.5～49.5)μg.mL-1浓度范围内,线性关系良好(r=0.9999)。平均回收率分别为100.2%,99.6%;RSD分别为0.83%,0.92%(n=9)。结论该法操作简单、准确、可靠,适用于复方罗红霉素片的质量研究。更多还原

【Abstract】 Objective To establish a HPLC method for the determination of the dissolution rate of Compound Roxithromycin Tablet.Methods The dissolution rate was determined by HPLC,with acetate buffer(pH 5.5)as dissolution medium and rotation speed at 100r·min-1,and the detection wavelength was 210nm.Results The good linear relationship and the average recovery rate for roxithromycin were in the range of(83.5～250.5)μg·mL-1(r=0.0999) and 100.2%,RSD=0.83%(n=9),respectively,while those for ambroxol hydrochloride were in the range of(16.5～49.5)μg·mL-1(r=0.0999) and 99.6%,RSD=0.92%(n=9),respectively.Conclusion The method is simple,accurate and reproducible,and it can be used for the determination of the dissolution rate of Compound Roxithromycin Tablets.更多还原