{"title":"分光光度法测定环糊精残留量的建立与验证百日咳抗原中的Heptakis","authors":"Bharat Shinde , Dadasaheb Patil , Vinod Nandre , Manish Gautam , Pooja Doshi , Sunil Gairola","doi":"10.1016/j.biologicals.2023.101663","DOIUrl":null,"url":null,"abstract":"<div><p><span><span>Methylated derivatives of cyclodextrins<span><span> such as DIMEB (2,6-di-O-methyl)-β-cyclodextrin or Heptakis is commonly used as culture medium modifier in manufacturing of pertussis<span><span> antigens for promoting the growth of bacteria. We report here development and validation of a spectrophotometric method for estimation of DIMEB in different product matrices of pertussis vaccine antigens i.e. Filamentous </span>haemagglutinin (FHA), </span></span>Pertactin<span> (PRN) and Pertussis toxin (PT). The detection is based on characteristic reaction of hydrolyzed sugars derivatives from DIMEB i.e., </span></span></span>furfural derivatives with anthrone reagent to form colored complexes which could be quantified at 625 nm. Method showed excellent linearity with correlation coefficient (R</span><sup>2</sup>) > 0.995 over the concentration of 5.0–80.0 μg. LOD and LOQ of 1.47 μg and 4.46 μg respectively was reported. The overall precision (repeatability and intermediate precision) showed % RSD for DIMEB content <10.0% for all the matrices. % Recoveries for DIMEB after three different spike levels (low, middle and high) were within 90%–113%. The method was successfully applied for determination of residual DIMEB in different product matrices of FHA, PRN and PT protein antigens. This can be used to monitor residual DIMEB levels during manufacturing of acellular pertussis antigens.</p></div>","PeriodicalId":1,"journal":{"name":"Accounts of Chemical Research","volume":null,"pages":null},"PeriodicalIF":16.4000,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Development and validation of a spectrophotometric method for quantification of residual cyclodextrin (DIMEB; Heptakis) in pertussis antigens\",\"authors\":\"Bharat Shinde , Dadasaheb Patil , Vinod Nandre , Manish Gautam , Pooja Doshi , Sunil Gairola\",\"doi\":\"10.1016/j.biologicals.2023.101663\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p><span><span>Methylated derivatives of cyclodextrins<span><span> such as DIMEB (2,6-di-O-methyl)-β-cyclodextrin or Heptakis is commonly used as culture medium modifier in manufacturing of pertussis<span><span> antigens for promoting the growth of bacteria. We report here development and validation of a spectrophotometric method for estimation of DIMEB in different product matrices of pertussis vaccine antigens i.e. Filamentous </span>haemagglutinin (FHA), </span></span>Pertactin<span> (PRN) and Pertussis toxin (PT). The detection is based on characteristic reaction of hydrolyzed sugars derivatives from DIMEB i.e., </span></span></span>furfural derivatives with anthrone reagent to form colored complexes which could be quantified at 625 nm. Method showed excellent linearity with correlation coefficient (R</span><sup>2</sup>) > 0.995 over the concentration of 5.0–80.0 μg. LOD and LOQ of 1.47 μg and 4.46 μg respectively was reported. The overall precision (repeatability and intermediate precision) showed % RSD for DIMEB content <10.0% for all the matrices. % Recoveries for DIMEB after three different spike levels (low, middle and high) were within 90%–113%. The method was successfully applied for determination of residual DIMEB in different product matrices of FHA, PRN and PT protein antigens. This can be used to monitor residual DIMEB levels during manufacturing of acellular pertussis antigens.</p></div>\",\"PeriodicalId\":1,\"journal\":{\"name\":\"Accounts of Chemical Research\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":16.4000,\"publicationDate\":\"2023-02-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Accounts of Chemical Research\",\"FirstCategoryId\":\"99\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1045105623000015\",\"RegionNum\":1,\"RegionCategory\":\"化学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CHEMISTRY, MULTIDISCIPLINARY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Accounts of Chemical Research","FirstCategoryId":"99","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1045105623000015","RegionNum":1,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CHEMISTRY, MULTIDISCIPLINARY","Score":null,"Total":0}
Development and validation of a spectrophotometric method for quantification of residual cyclodextrin (DIMEB; Heptakis) in pertussis antigens
Methylated derivatives of cyclodextrins such as DIMEB (2,6-di-O-methyl)-β-cyclodextrin or Heptakis is commonly used as culture medium modifier in manufacturing of pertussis antigens for promoting the growth of bacteria. We report here development and validation of a spectrophotometric method for estimation of DIMEB in different product matrices of pertussis vaccine antigens i.e. Filamentous haemagglutinin (FHA), Pertactin (PRN) and Pertussis toxin (PT). The detection is based on characteristic reaction of hydrolyzed sugars derivatives from DIMEB i.e., furfural derivatives with anthrone reagent to form colored complexes which could be quantified at 625 nm. Method showed excellent linearity with correlation coefficient (R2) > 0.995 over the concentration of 5.0–80.0 μg. LOD and LOQ of 1.47 μg and 4.46 μg respectively was reported. The overall precision (repeatability and intermediate precision) showed % RSD for DIMEB content <10.0% for all the matrices. % Recoveries for DIMEB after three different spike levels (low, middle and high) were within 90%–113%. The method was successfully applied for determination of residual DIMEB in different product matrices of FHA, PRN and PT protein antigens. This can be used to monitor residual DIMEB levels during manufacturing of acellular pertussis antigens.
期刊介绍：
Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance.
Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.
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