An improved size exclusion-HPLC method for molecular size distribution analysis of immunoglobulin G using sodium perchlorate in the eluent

Wang, Hsiaoling; Levi, Mark S.; Grosso, Alfred V. Del; McCormick, William; Bhattacharyya, Lokesh

doi:10.1016/j.jpba.2017.02.025

Cited by 13 publications

(2 citation statements)

References 23 publications

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“…This method enables the determination of high molecular weight components (Arakawa et al, 2010; den Engelsman et al, 2011; Gabrielson et al, 2007; Goyon, Beck, et al, 2017; Hong et al, 2012; Kueltzo et al, 2008; Tantipolphan et al, 2010; Wakankar et al, 2011). Although SEC is the method of choice for the characterization of aggregate size and content, it has limitations in the biopharmaceutical analysis, such as challenging detection of oligomers, possible protein clogging (Sahin et al, 2012), protein adsorption in the column and system (Wang, Levi, et al, 2017), possible aggregate dissociation (Arosio et al, 2013), and method condition‐induced aggregation (Arakawa et al, 2010; Bobaly et al, 2016; Carpenter et al, 2010; Staub et al, 2011; Philo, 2009). To mitigate some of these issues, the following conditions can be used: (i) salts at a higher concentration or chaotropic agent in the mobile phase, (ii) columns with sub‐3 µm particles having well‐defined pore sizes (Goyon, D'Atri, et al, 2017), and (iii) stationary phase chemistry reducing the secondary interactions (Arakawa et al, 2010; Bouvier & Koza, 2014; Wakankar et al, 2011).…”

Section: Ms‐based Methods In the Analysis Of Biopharmaceuticalsmentioning

confidence: 99%

What is the role of current mass spectrometry in pharmaceutical analysis?

Khalikova

Jireš

Horáček

et al. 2023

Mass Spectrometry Reviews

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The role of mass spectrometry (MS) has become more important in most application domains in recent years. Pharmaceutical analysis is specific due to its stringent regulation procedures, the need for good laboratory/manufacturing practices, and a large number of routine quality control analyses to be carried out. The role of MS is, therefore, very different throughout the whole drug development cycle. While it dominates within the drug discovery and development phase, in routine quality control, the role of MS is minor and indispensable only for selected applications. Moreover, its role is very different in the case of analysis of small molecule pharmaceuticals and biopharmaceuticals. Our review explains the role of current MS in the analysis of both small‐molecule chemical drugs and biopharmaceuticals. Important features of MS‐based technologies being implemented, method requirements, and related challenges are discussed. The differences in analytical procedures for small molecule pharmaceuticals and biopharmaceuticals are pointed out. While a single method or a small set of methods is usually sufficient for quality control in the case of small molecule pharmaceuticals and MS is often not indispensable, a large panel of methods including extensive use of MS must be used for quality control of biopharmaceuticals. Finally, expected development and future trends are outlined.

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Section: Ms‐based Methods In the Analysis Of Biopharmaceuticalsmentioning

confidence: 99%

What is the role of current mass spectrometry in pharmaceutical analysis?

Khalikova

Jireš

Horáček

et al. 2023

Mass Spectrometry Reviews

View full text Add to dashboard Cite

show abstract

“…Hence it is of great value to develop simple and effective sample pretreatment technologies. At present, several sample pretreatment technologies have been established such as supercritical-fluid extraction, liquid-liquid microextraction, size-exclusion chromatography, solid-phase microextraction, solid-phase extraction, dispersive solid-phase extraction, and so on [23][24][25][26][27][28][29][30][31][32][33][34]. Among them, solid-phase extraction (SPE), an effective technology in environment sample pretreatment, has been widely used for the enrichment of environmental pollutants on account of its simplicity, good enrichment efficiency, and less consumption of toxic solvent [35].…”

Section: Introductionmentioning

confidence: 99%

Determination of Sudan red contaminants at trace level from water samples by magnetic solid-phase extraction using Fe@NiAl-layered double hydroxide coupled with HPLC

Zhou

Yuan

et al. 2019

Environ Sci Eur

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Background: Sudan red dyes are widely used as color additions in various fields. Due to their potential carcinogenicity and large consumption, they have absorbed much more attention and become a research hot topic. There have been a few of existing methods for their analysis from samples; however, it is of great importance to develop simple, sensitive, and low-cost analytical method for public health and safety. This article described a new method based on magnetic Fe@NiAl-layered double hydroxides for enrichment of Sudan red dyes in combination with high-performance liquid chromatography. Results: The as-prepared magnetic Fe@NiAl-layered double hydroxides (Fe@NiAl-LDHs) exhibited good adsorption capacity for Sudan red dyes, and could be used as an effective adsorbent for preconcentration of three Sudan Red dyes from environmental water samples. The proposed method provided low limits of detection in the range of 0.002-0.005 μg L −1 with magnetic solid-phase extraction in combination with high-performance liquid chromatography. Conclusion: The developed method utilized the easy to prepare magnetic materials as adsorbents and conventional analytical instrument and provided high sensitivity, which provided a robust and low consumption of toxic organic solvent alternative method. The results of present study are of great value for interested laboratories to monitor the level of Sudan red dyes in water samples or develop sensitive determination methods to monitor other pollutants at trace level in environmental waters.

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