Development and validation of a spectrophotometric method for quantification of residual cyclodextrin (DIMEB; Heptakis) in pertussis antigens

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY

Accounts of Chemical Research Pub Date : 2023-02-01 DOI:10.1016/j.biologicals.2023.101663

Bharat Shinde , Dadasaheb Patil , Vinod Nandre , Manish Gautam , Pooja Doshi , Sunil Gairola

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引用次数: 0

Abstract

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.

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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

环糊精的甲基化衍生物，如DIMEB（2,6-二-O-甲基）-β-环糊精或Heptakis，通常用作百日咳抗原生产中的培养基改性剂，以促进细菌生长。我们在此报道了一种分光光度法的开发和验证，该方法用于估算百日咳疫苗抗原的不同产物基质中的DIMEB，即丝状血凝素（FHA）、百日咳肌动蛋白（PRN）和百日咳毒素（PT）。检测基于来自DIMEB的水解糖衍生物的特征反应，即糠醛衍生物与蒽酮试剂形成可在625nm下定量的有色络合物。方法显示出良好的线性，相关系数（R2）>；在5.0–80.0μg的浓度范围内为0.995。LOD和LOQ分别为1.47μg和4.46μg。总体精密度（重复性和中间精密度）显示DIMEB含量的%RSD<；所有矩阵的10.0%。%在三种不同的尖峰水平（低、中、高）后，DIMEB的回收率在90%-113%之间。该方法已成功应用于FHA、PRN和PT蛋白抗原不同产物基质中残留DIMEB的测定。这可用于在无细胞百日咳抗原的制造过程中监测残留的DIMEB水平。

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来源期刊

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

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.