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确认盐酸米托蒽醌含量和相关物质高效液相色谱检测方法 被引量:3

Validate the Analysis Method Assay and Related Substances in Mitoxantrone Hydrochloride by HPLC
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摘要 我们按照ICH指南Q2A Q2B的验证要求,对盐酸米托蒽醌含量和相关物质的高效液相色谱检测方法进行确认,结果表明:该方法具有良好的系统适应性,方法专属性以及方法中间精密度和方法耐用性。该方法适合盐酸米托蒽醌含量和相关物质的检测。 According to the requirement of ICH guidelines Q2 A and Q2 B, we validate the Analysis Method assay and related substances in Mitoxantrone Hydrochloride, the validation results shown that: the system suitability is good, and the method has good method specificity. The method is suitable for detection of the Analysis Method assay and related substances in Mitoxantrone Hydrochloride.
出处 《广东化工》 CAS 2015年第16期199-200,共2页 Guangdong Chemical Industry
关键词 盐酸米托蒽醌 相关物质 高效液相色谱 Mitoxantrone Hydrochloride related substances HPLC
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参考文献7

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二级参考文献3

  • 1The United States Pharmacopoeial Convention.The United States Pharmacopeial[M].32th edi.Rockville MD:the United States Pharmacopoeial Convention Inc.,2009:2 994.
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