| 盐酸氨基葡萄糖胶囊有关物质测定方法研究 |
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| 引用本文： | 张德柱,宋愿智,沈登林.盐酸氨基葡萄糖胶囊有关物质测定方法研究[J].西北药学杂志,2014(3):252-255. |
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| 作者姓名： | 张德柱 宋愿智 沈登林 |
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| 作者单位： | [1]陕西盘龙制药集团有限公司,柞水711400; [2]陕西省食品药品检验所,西安710065 |
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| 摘 要： | 目的建立测定盐酸氨基葡萄糖胶囊有关物质的高效液相色谱方法。方法采用C18柱(250mm×4.6mm,5μm);以庚烷磺酸钠溶液(0.5g庚烷磺酸钠溶解在水中,加0.5mL磷酸,再加0.224g氢氧化钾,加水稀释至1 000mL,摇匀)-乙腈(1 000∶50)为流动相;流速1.0mL·min-1;检测波长:195nm;柱温:室温。结果盐酸氨基葡萄糖胶囊对酸稳定,对碱、高温、强氧化破坏不稳定,其线性范围为6.3231.60μg·mL-1。结论此方法简便,准确,快速,专属性强,可用于该制剂的有关物质检查。
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| 关 键 词： | HPLC法 盐酸氨基葡萄糖胶囊 有关物质 |
Determination of related substances in Glucosamine Hydrochloride Capsules |
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| Institution: | ZHANG Dezhu, SONG Yuanzhi, SHEN Denglin(1. Shaanxi Panlong Pharmaceutical Group Limited Company, Zhashui 711400;2. Shaanxi Institute for Food and Drug Control,Xi＇an 710065 ,China) |
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| Abstract: | Objective To establish an HPLC method for the determination of related substances in Glucosamine Hydrochloride Cap-sules .Methods The separation was performed on a C18 （250 mm × 4 .6 mm ,5 μm） column at room temperature .The mobile phase was a mixture of sodium 1-heptanesulfonate solution and acetonitrile at a flow-rate of 1 .0 mL · min-1 .The detection wave-length was at 195 nm .Results The Glucosamine Hydrochloride Capsules was stable with acid destruction ,but unstable with alka-li ,high temperature and strong oxidative destruction .The linear range was 6 .32-31 .60 μg · mL -1 .Conclusion This method is simple ,accurate ,and rapid with high specificity .It is applicable for the determination of related substances in Glucosamine Hydro-chloride Capsules . |
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| Keywords: | HPLC Glucosamine Hydrochloride Capsules related substances |
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