如何生成真实的色谱结果？
作为分析化学家，您的主要问题是在任何其他实验室的相同条件下产生普遍接受和可重复的真实数据。即使使用大多数复杂的乐器也不会为全球接受的规范忽视而不用宗旨。系统适用性是化学分析中产生有效数据的关键。
我特别色谱法,液相色谱法s the most popular technique in laboratories engaged in pharmaceuticals, foods, forensics, polymers, life sciences and environmental studies. Thousands of HPLC’s are working in research and development and quality control laboratories in pharmaceuticals sector alone across the world. Immense amount of data is generated daily which contributes in developing safe and efficacious drugs for human consumption. Given the seriousness of such activity it is of utmost significance that the HPLC systems should satisfy the requirements of system suitability before decisions are taken on basis of such data.
What is System Suitability?
系统适用性测试构成了色谱分析的重要组成部分。它们帮助我们决定检测灵敏度，分辨率和再现性足以进行所需分析。美国药典（USP）是药物类别色谱指导方针的权威来源。第621节USP指出系统适用性测试是气体和液相色谱分析的组成部分。该测试基于待分析的设备，电子，分析操作和样本构成可以评估的积分系统。这意味着除非已满足系统适用性的要求，否则不会接受样品分析。
有助于系统适用性失败在HPLC分析中的因素
- Auto sampler – Poor precision due to inability to deliver precisely the set volumes of samples and standards.
- 柱子 - 老化柱或窒息的柱可能导致由于理论板数量的减少而导致的性能差。
- 泵 - 由于操作部件的磨损而导致移动相位恒定流速
- Mobile phase- errors in making prescribed mixtures and incomplete degassing
- Sample and reference preparation – inaccuracies in preparation or non-filtration before injection
系统适用性测试多久一次？
根据监管机构指南，系统适用性应限定整个色谱系统，而不仅仅是单个模块。每当设备有重大变化或在关键试剂系统中，应在注射样品之前进行测试。除非已经满足了系统适用性的要求，否则无法接受样品分析。获得的样本分析结果，而系统则失效系统适用性的要求没有意义。
System suitability must be performed before and throughout all regulated assays. It is not sufficient to apply suitability tests at the beginning of the chromatographic run and assume that the system will perform properly during the run. Test mixtures containing main components and expected impurities can be injected at the beginning and interspersed during testing.
面对系统适用性失败，分析师应立即停止分析。在诊断问题并采取补救措施后，应重做适合性测试。只有在满足所有系统适用性标准，不仅是失败的标准之后，才会恢复实际样本的分析。
Shold we do the system suitablity test with the standard solution or with sample( eg. Plasma sample)?? Is there any guideline that we can follow for system suitability test??
系统适用性通常与标准运行，以检查电影系统的性能，同时使用质量控制样品检查整个方法的性能（样品制备和色谱），因此两者都应以序列运行。
Thank you for the information.
这很有趣
感谢您的欣赏。在昨天发布的第二部分上。
尊敬的先生，
Are there any special points other that those said in the article that must be noted when outsourcing HPLC analyses for QC purposes?
请回应。
Kind Regards
你好，
At time of outsourcing HPLC analysis besides the points covered in the article you should ensure that the method used by the outsourced laboratory or recommended by you is a validated method and also the analyst doing the analys has received adequate level of training and his expertise has been validated.
Best Regards
尊敬的先生，
Thank you so much for your reply.
我会找到相同的方法。
Best Regards
Thank you so much for posting the valuable information.
Glad to note that you found the information useful.
尊敬的先生，
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嗨Siraj，我们的在线HPLC课程//www.drakkus.com/product/join-our-certificate-course-on-hplc/在Excome Elite软件上进行培训，并详细介绍了使用任何色谱软件的基本概念。