One-hour screening of adulterated heparin by simplified peroxide digestion and fast RPIP-LC-MS(2)
Research article published in Analytical chemistry (2015)
Abstract
Early detection of potential contaminants in heparin, an extensively used anticoagulant in drug formulations and medical devices, is critical to ensuring public health. In response to heparin adulteration by oversulfated chondroitin sulfates (OSCS) that was associated with adverse events including deaths in 2007-2008, many methods have been developed to detect OSCS in heparin. However, an analytical challenge for quality screenings has been to speed up these measurements to address the complex distribution scheme of heparin in today's global market. Here an approach based on mass spectrometry is described that enables the measurement of adulterated heparin in 1 h, significantly shortening the time frame of screening for potential contaminants. The methodology is based on simplified peroxide digestion that rapidly depolymerizes large polysaccharide chains to small oligosaccharides followed by fast liquid chromatography mass spectrometry to determine sample purity. We find that rapid peroxide digestion generates abundant C- and Y-type oligosaccharides that can be used to differentiate parent glycosaminoglycans via unsupervised multivariate analysis, including heparin, chondroitin sulfate A, dermatan sulfate, and the infamous OSCS. With quantitation demonstrated at 1% (w/w), or 50 ng, OSCS in heparin and the lower limit of detection estimated at ∼0.20% (w/w), or ∼10 ng, OSCS in heparin, the technology was sufficiently sensitive to differentiate real-life, "authentic" adulterated heparin samples and to quantify this contaminant with an error <10% relative standard deviation. The methodologies presented here are deliberately simple to foster adoption and increase the analytical throughput of mass spectrometric screening in the routine quality assessment of heparin and other types of compounds of this molecular family.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Резюме
Early detection of potential contaminants in heparin, an extensively used anticoagulant in drug formulations and medical devices, is critical to ensuring public health.
Почему это важно для гирудотерапии
This article describes a rapid analytical method for detecting oversulfated chondroitin sulfate (OSCS) adulteration in heparin products using simplified peroxide digestion followed by fast liquid chromatography mass spectrometry, achieving total analysis time of approximately one hour with quantitation at 1% (w/w) OSCS and a lower detection limit of ~0.20%. The methodology was validated against real-life adulterated heparin samples and could differentiate multiple glycosaminoglycan types including heparin, chondroitin sulfate A, dermatan sulfate, and OSCS. This quality-control tool addresses heparin safety following the 2007–2008 adulteration crisis. The article has no connection to hirudotherapy, leeches, hirudin, or the leech secretome; it is exclusively about heparin contamination screening.
Цитирование
One-hour screening of adulterated heparin by simplified peroxide digestion and fast RPIP-LC-MS(2)
Li H et al. · Analytical chemistry, 2015
Связанный клинический контекст
Узнайте, как это исследование связано с клинической практикой
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