One identification test method of current drug product specification is to compare the retention time in the assay by HPLC. Can the retention time of HPLC in other test items be added as another identification test method?

刊登日期:2019-11-22  |  點閱次數 : 1541 次 

It is not recommended. The identification method should be established according to the characteristics of drug product. Due to poor specificity of chromatographic retention time, the use of two chromatographic procedures, where the separation is based on different principles, or combination of tests into a single procedure, such as HPLC/UV diode array, HPLC/MS, or GC/MS, is generally acceptable. It is recommended following ICH Q6A.



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