| 高效液相色谱法测定复方罗红霉素片的溶出度 |
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| 引用本文： | 戚苏民,刘江华,陆宏国,周丽英,周斌.高效液相色谱法测定复方罗红霉素片的溶出度[J].中国现代医生,2010,48(34):104-105. |
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| 作者姓名： | 戚苏民 刘江华 陆宏国 周丽英 周斌 |
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| 作者单位： | [1]扬子江药业集团有限公司药物制剂新技术国家重点实验室,江苏泰州225321 [2]江苏扬子江药物研究院,江苏泰州225321 |
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| 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EIPLC法。方法以醋酸盐缓冲液（pn5．5）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。
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| 关 键 词： | 罗红霉素 盐酸氨溴索 片剂 高效液相色谱法 溶出度 |
Determination of Dissolution Rate of Compound Roxithromycin Tablets by HPLC |
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| Authors: | QI Sumin LIU Jianghua LU Hongguo ZHOU Liying ZHOU Bin |
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| Institution: | 1.State Key Laboratory for New Technology of Pharmaceutical Preparations,Yangtze River Pharmaceutical Group Co.,Ltd.,Taizhou 225321, China;2.Jiangsu (Yangtze River) New Drug Research Institute,Taizhou 225321,China) |
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| 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 （83.5-2505）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. |
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| Keywords: | Roxithromycin Ambroxol hydrochloride Tablet HPLC Dissolution |
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