| HPLC法测定盐酸氨溴索注射液的含量和有关物质 |
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| 引用本文： | 付建,苏贵勇,赵海桥.HPLC法测定盐酸氨溴索注射液的含量和有关物质[J].齐鲁药事,2012,31(2):84-87. |
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| 作者姓名： | 付建 苏贵勇 赵海桥 |
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| 作者单位： | 1. 山东方明药业集团股份有限公司,山东,菏泽,274500;中国药科大学,江苏,南京,210009
2. 山东方明药业集团股份有限公司,山东,菏泽,274500;山东大学药学院,山东,济南,250012 |
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| 摘 要： | 目的建立高效液相色谱法测定盐酸氨溴索注射液的含量和有关物质的方法。方法采用Welchrom-C18(4.6 mm×200 mm,5μm)色谱柱,流动相为0.01 mol.L-1磷酸氢二铵溶液(用磷酸调pH值至7.0)-乙腈(50∶50),流速为1.0 mL.min-1,检测波长为248 nm。结果盐酸氨溴索在0.091～0.212 mg.mL-1范围内线性关系良好,相关系数r=0.999 9,平均回收率为99.60%(n=9)。结论采用高效液相色谱法测定盐酸氨溴索注射液的含量和有关物质,方法简便,结果准确可靠。
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| 关 键 词： | 盐酸氨溴索注射液 含量测定 有关物质 高效液相色谱法 |
Determination of Ambroxol Hydrochloride Injection and its related substances by HPLC |
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| FU Jian,SU Gui-yong,ZHAO Hai-qiao.Determination of Ambroxol Hydrochloride Injection and its related substances by HPLC[J].qilu pharmaceutical affairs,2012,31(2):84-87. |
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| Authors: | FU Jian SU Gui-yong ZHAO Hai-qiao |
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| Affiliation: | 1. Shandong Fangming Pharmaceutical Co. , Ltd. , Heze 274500, China ;2. China Pharmaceutical University, Nanjing 210009, China ;3. School of Pharmaceutical Sciences, Shandong University, Jinan 250012, China) |
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| Abstract: | Objective To establish an HPLC method for determination of the content and the related substances of Ambroxol Hydrochloride Injection. Methods The Welehrom - Cls column （ 4.6 mmx 200 mm ,5 p,m ） was adopted. The mobile phase was 0.01 mol · L^-1 diammonium phosphate （ adjusted the pH to 3.0 with phosphate ） - acetonitrile （ 50：50 ）, the flow rate was 1.0 mL · min^-1and the detection wavelength was 248 nm. Results Ambroxol hydrochloride showed a good linear relationship within the range of 0.091 - 0.212 mg · mL ^- 1（ r = 0. 999 9 ） and the average recovery was 99.60% （ n = 9 ）. Conclusion This method was simple, accurate and reliable for the determination of Ambroxol Hydrochloride Injection and its related substances. |
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| Keywords: | Ambroxol Hydrochloride Injection Determination Related substances HPLC |
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