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UPLC Application In Analysis Of Meropenem

Posted on:2021-02-26Degree:MasterType:Thesis
Country:ChinaCandidate:T LiFull Text:PDF
GTID:2404330605455539Subject:Biological engineering
Abstract/Summary:PDF Full Text Request
In this paper,based on the high performance liquid chromatography(HPLC)method of the 2015 edition of the Chinese Pharmacopoeia,and the need for release efficiency in the actual detection process,an ultra performance liquid chromatography(UPLC)method was developed and established for the determination of meropenem content and related substances,from the study of chromatographic theory to the understanding of UPLC analysis,and the method conversion technique was studied,and finally the UPLC analysis method was developed and optimized.Due to the special nature of the drug release,the necessary validation of the method is required,so the applicability of the method of analysis of the content of the raw drug meropenem and related substances was investigated,and the method was validated methodologically.Validation conclusion shows that the specific properties,detection limit LOD,limit LOQ,linearity and range,accuracy,precision and durability all met the requirements,and the content solution was stable within 10 hours at 15?,and due to the severe degradation of meropenem,especially the growth of impurity A and B.Compared with the original method of HPLC,the running time of each needle is reduced from the original 50 minutes to the current 15 minutes.Due to the reduction of the collection time per injection to a quarter of the original level,and the conversion of the flow rate from 1.4m L/min to 0.2m L/min,the reagent used was only one twentieth of the original level.The comparison between the original HPLC and UPLC methods shows that the newly developed UPLC method has the same accuracy as the pharmacopoeia HPLC method and has obvious advantages over the original method in terms of efficiency and environmental protection.
Keywords/Search Tags:UPLC, meropenem, assay, related substances, analytical method, development and verification
PDF Full Text Request
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