摘要
目的：建立盐酸氨溴索含量分析的方法学。方法色谱柱为 Agilent ZORBAX SB -C18，流动相为0．01mol/L磷酸氢二铵溶液（用磷酸调节pH值至7．0）-乙腈（50：50），流速为1．0mL /min，检测波长为248nm，进样量为20μl。结果辅料干扰试验结果表明其它各原辅料不影响本品盐酸氨溴索的含量测定；线性关系试验结果表明盐酸氨溴索（C13H18Br2N2O· HCl）在5．8688μg/ml-52．8192μg/ml范围内，浓度与峰面积呈良好线性关系；精密度试验本法精密度较好；溶液稳定性试验表明本品溶液在8小时内稳定性较好；回收率试验表明本法回收率较好；含量测定试验表明本品各批供试品盐酸氨溴索的含量均符合规定。
Abstract
Objective Establish hydrochloric acid ammonia bromine content analysis methodology .Method column is Agilent ZORBAX SB -C18,mobile phase:Ph=7.0 Phosphoric acid buffer solution -acetonitrile(HPLC grade)(50:50),flow rate:1.0ml/min,detection:at 248 nm,injection:20uL.Result complementary makings interference test,the linear relationship between test,precision test,recovery test and content determination test show that hydrochloric acid ammonia bromine meet the re-quirements.
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