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。
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 （83.5-2505）μg·mL^-1（r=0.0999） and 100.2% ,RSD=0.83%（n=9）, respectively,while those for ambroxol hydrochlorlde 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 Roxithromyein Tablets.
出处
《中国现代医生》
2010年第34期104-105,共2页
China Modern Doctor
