| 高效液相色谱法测定盐酸巴尼地平相关物质 |
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| 引用本文： | 万琼,唐永丰,刘云华.高效液相色谱法测定盐酸巴尼地平相关物质[J].中国医药指南,2011,9(29):216-217. |
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| 作者姓名： | 万琼 唐永丰 刘云华 |
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| 作者单位： | 1. 湖北百科亨迪药业有限公司,湖北,荆门,448000
2. 湖北荆门第二人民医院药剂科,湖北,荆门,448000 |
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| 摘 要： | 目的建立原料药盐酸巴尼地平有关物质检查方法。方法参照《中国药典》2010年版二部附录,采用高效液相色谱仪进行。结果盐酸巴尼地平浓度在0.336~6.045μg/mL范围内溶液峰面积与浓度成线性关系,相关系数为0.9992;定量限和检测限信噪比能够达到检测要求;回收率分别为100.9%、101.7%、98.8%、97.7%。结论该方法专属性好,精密度、准确度都符合规定,方法可靠,可用于原料药盐酸巴尼地平相关物质的控制。
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| 关 键 词： | 盐酸巴尼地平 HPLC 有关物质检测 |
Determination of Related Substance in Barnidipine Hydrochloride by HPLC |
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| WAN Qiong,TANG Yong-feng,LIU Yun-hua.Determination of Related Substance in Barnidipine Hydrochloride by HPLC[J].Guide of China Medicine,2011,9(29):216-217. |
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| Authors: | WAN Qiong TANG Yong-feng LIU Yun-hua |
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| Institution: | 1 Hubei Biocause heilen Pharmaceutical Co.,Ltd,Jingmen 448000,China;2 Department of Pharmaceutic of Jingmen the second People′s Hospital,Jingmen 448000,China) |
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| Abstract: | Objective To establish a method for testing Related Substance for Barnidipine hydrochloride.Method HPLC Injecting were conducted according to the appendix of the Chinese Pharmacopoeia（edition 2010）.Result The calibration curves were linear within the range of 0.336~6.045μg/mL for Barnidipine hydrochloride（r=0.9992）,Limit of Detection and Limit of Quantif ication were therefore found suitable for its intended application.The recovery rate were100.9%、101.7%、98.8%、97.7% respectively.Conclusion The method is simple,sensitive,accurate and suitable for the quality control of this drug substance. |
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| Keywords: | Barnidipine hydrochloride HPLC Related Substance test |
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