药物分析（pharmaceutical analysis）.doc

药物分析（pharmaceutical analysis） Trends in the design of suitability test for high performance liquid chromatography systems Classification: liquid knowledge Effective liquid chromatography (HPLC) is a qualitative and quantitative chromatographic analysis method commonly used in drug analysis. It has strong specificity, relatively high detection sensitivity and good quantization function. The 2005 edition of Pharmacopoeia method using HPLC China varieties, applicability test design of chromatographic system has changed: index more meticulous and thoughtful, more pragmatic, applicability test of chromatographic system with solution preparation methods are also diversified, reflect some tendency. The suitability of the 1. chromatographic system test design is more matched with the experimental purpose The precise degree of suitability of the system depends on the purpose of the experiment. First of all, we should consider what kind of experiment the chromatographic system is used and design the suitability test of the system according to the experimental purpose. If a HPLC method is only used for qualitative identification, the test of the applicability of the chromatographic system can be relatively simple and relaxed, as long as it can ensure that the measured component peak and other peaks have a certain degree of separation, with suitable peak time can achieve the purpose of the experiment. If used for quantitative analysis (such as determination), in addition to ensure that the measured component peaks with suitable peak time, it also needs to check whether the system can ensure that the measured peak components completely separated from other peaks, the degree of separation in general should be more than 1.5, should also be tested into repetitive peak peak the area is good, the control of peak area solution injection needle 5 relative standard deviation should be no greater than 2%, the measured peak peak components should also be symmetrical, in order to ensure th