A Size-Exclusion Chromatography Method for Analysis of Clostridium difficile Vaccine Toxins

Author(s):  
Catherine Lancaster ◽  
Richard R. Rustandi ◽  
Paola Pannizzo ◽  
Sha Ha
2015 ◽  
Vol 65 (1) ◽  
pp. 43-52 ◽  
Author(s):  
Maja Radivojša Matanović ◽  
Iztok Grabnarm ◽  
Pegi Ahlin Grabnar ◽  
Robert Roškar

Abstract Heparin is widely used as an anticoagulant for the treatment and prevention of various thrombotic diseases. However, due to its high anionic charge, heterogeneity in size distribution and high polarity, its analysis is very challenging. In this paper, a novel method based on size-exclusion chromatography (SEC) for quantitative determination of intact heparin in pharmaceuticals is presented. Analyses were performed on a BioSep-SEC-S 2000 column with Larginine solution at pH 6.5 as mobile phase and UV detection at 210 nm. The proposed method was found to be selective, linear (R2 > 0.997) over the concentration range of 3.1 to 1222 μg mL-1, with a limit of detection of 1.0 μg mL-1. Intraday and inter-day precision were below 5.1 % and inaccuracy expressed as bias did not exceed 6.5 %. The reported method is simple, selective, sensitive, and requires no laborious sample preparation, which makes it appropriate for routine quantitative analysis of heparin in pharmaceuticals


Molecules ◽  
2021 ◽  
Vol 26 (17) ◽  
pp. 5360
Author(s):  
Luis Antonio Suárez-Hernández ◽  
Rosa María Camacho-Ruíz ◽  
Enrique Arriola-Guevara ◽  
Eduardo Padilla-Camberos ◽  
Manuel Reinhart Kirchmayr ◽  
...  

The hyaluronic acid (HA) global market growth can be attributed to its use in medical, cosmetic, and pharmaceutical applications; thus, it is important to have validated, analytical methods to ensure confidence and security of its use (and to save time and resources). In this work, a size-exclusion chromatography method (HPLC-SEC) was validated to determine the concentration and molecular distribution of HA simultaneously. Analytical curves were developed for concentration and molecular weight in the ranges of 100–1000 mg/L and 0.011–2.200 MDa, respectively. The HPLC-SEC method showed repeatability and reproducibility greater than 98% and limits of detection and quantification of 12 and 42 mg/L, respectively, and was successfully applied to the analysis of HA from a bacterial culture, as well as cosmetic, and pharmaceutical products.


2018 ◽  
Vol 90 (21) ◽  
pp. 12390-12394 ◽  
Author(s):  
Yile Li ◽  
Xiangchun E. Wang ◽  
Michael F. Bender ◽  
Rong Yang ◽  
Taryn J. Cozine ◽  
...  

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