| 高效液相色谱法测定罗红霉素胶囊的溶出度 |
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| 引用本文： | 郑小敏,舒德忠,熊胜元. 高效液相色谱法测定罗红霉素胶囊的溶出度[J]. 中国药业, 2008, 17(24): 31-32 |
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| 作者姓名： | 郑小敏 舒德忠 熊胜元 |
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| 作者单位： | 1. 重庆涪陵药检所,重庆,408000
2. 重庆涪陵中心医院,重庆,408000 |
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| 摘 要： | 目的建立测定罗红霉素胶囊溶出度的高效液相色谱（HPLC）法。方法HPLC法测定采用Shimadzu VP-ODSC C18柱（250mm×4．6mm，5μm），以水-乙腈-0．1mol／L磷酸二氢铵（1：2：2）为流动相，流速为1．0mL／min，检测波长为215nm。结果罗红霉素胶囊质量浓度在0．02574-1．0296g／L范围内与峰面积线性关系良好（r=0．9997），平均回收率为99．9％，RSD=0．7％（n=7），2批样品的40min溶出度均在70％以上。结论HPLC法简便、准确、可靠，且不易受外界因素影响，可用于罗红霉素胶囊溶出度的测定。
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| 关 键 词： | 罗红霉素 高效液相色谱法 溶出度 |
Determination of Dissolution of Roxithromycin Capsules by HPLC |
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| Zheng Xiaomin,Shu Dezhong,Xiong Shengyuan. Determination of Dissolution of Roxithromycin Capsules by HPLC[J]. China Pharmaceuticals, 2008, 17(24): 31-32 |
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| Authors: | Zheng Xiaomin Shu Dezhong Xiong Shengyuan |
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| Affiliation: | Zheng Xiaomin,Shu Dezhong,Xiong Shengyuan(1. Fuling District Institute of Drug Control, Chongqing, China 408000; 2. Fuling District Central Hospital, Chongqing, China 408000) |
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| Abstract: | Objective To establish a HPLC method for the dissolution determination of Roxithromycin Capsules. Methods The separation was performed on the VP-ODS C18 column, the mobile phase consisted of water-acetonitrile-0. 1 mol/L ammonium dihydrogen phosphate（1： 2 ： 2） with the flow rate of 1.0 mL/min, the detection wavelength was at 215 nm. Results The good linearity in the range of 0. 025 74 - 1.029 6 g/L was showed（ r= 0. 999 7）, and its average recovery rate was 99.9% （RSD =0. 7% ）. The dissolutions of 2 batches of samples were all above 70%. Conclusion The method is simple, accurate, reliable and suitable for the dissolution determination of Rox- ithromyein Capsules. |
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| Keywords: | Roxithromycin Capsules HPLC dissolution |
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