| HPLC法测定注射用盐酸氨溴索中的含量及有关物质 |
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| 引用本文： | 纪传侠,孟科,李雯,宋莲芳.HPLC法测定注射用盐酸氨溴索中的含量及有关物质[J].化工时刊,2008,22(4):40-42. |
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| 作者姓名： | 纪传侠 孟科 李雯 宋莲芳 |
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| 作者单位： | 1. 安徽丰原集团有限公司
2. 安徽丰原生物化学股份有限公司,安徽,蚌埠,233010 |
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| 摘 要： | 采用Diamonsil C18柱（200mm×4．6mm，5μm），以0．1mol／L磷酸二氢钾（pH值7．04-0．05）-乙腈（40：60）为流动相，流速为1．0mL·min^-1，检测波长为248nm，柱温：室温。建立高效液相色谱法测定注射用盐酸氨溴索中盐酸氨溴索的含量及有关物质。盐酸氨溴索的线性范围为20-100 μg·mL^-1，相关系数r=0．9997；平均回收率为99．90％（n=9）。该方法简便、准确、专属，可用于注射用盐酸氨溴索的含量及有关物质的测定。
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| 关 键 词： | 盐酸氨溴索 注射用 HPLC法 物质 测定 高效液相色谱法 磷酸二氢钾 平均回收率 |
| 修稿时间： | 2008年3月5日 |
Determination of Ambroxol Hydrochloride for Injection and Its Related Substances by HPLC |
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| Ji Chuanxia,Meng Ke,Li Wen,Song Lianfang.Determination of Ambroxol Hydrochloride for Injection and Its Related Substances by HPLC[J].Chemical Industry Times,2008,22(4):40-42. |
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| Authors: | Ji Chuanxia Meng Ke Li Wen Song Lianfang |
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| Affiliation: | Ji Chuanxia ,Meng Ke, Li Wen ,Song Lianfang (Anhui BBCA Group Co. Lt; ＊ Anhui BBCA Biochemical Group Corp, Anhui Bengbu 233010) |
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| Abstract: | A HPLC method was established for the determination of ambroxol hydrochloride and its related substances in ambroxol hydrochloride for injection. A Diamonsil C18 column（200 mm ×4.6 mm,5 μm）was used . The mobile phase was 0. 1moL/L phosphate buffer （pH 7.0 ± 0.05） -acetonitrile （40：60）. The detection wavelength was 248 nm and flow rate was 1.0 mL · min ^- 1. Column temperature was room temperature. The calibration curve of ambroxol hydrochloride was linear between 20 - 100 μg · mL^- 1 （ r = 0.999 7 ）. An average recovery of 99.90% was obtained （ n = 9）. The method was simple, accurate,specific and was suitable for the determination of ambroxol hydrochloride and its related substances in ambroxol hydrochloride for injection. |
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| Keywords: | HPLC ambroxol hydrochloride related substances determination |
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