Biomonitoring of Epichlorohydrin by Hemoglobin Adducts

Landin, Helena Hindsø; Osterman-Golkar, Siv; Zorcec, V.; Törnqvist, Margareta

doi:10.1006/abio.1996.0322

Cited by 55 publications

(30 citation statements)

References 2 publications

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“…Also, the existing methods [10–14] involved derivatization procedures, adduct analysis, SPME fibers with thermal desorption, mass and electrochemical detectors for ECH determination only on clean sample matrices. The proposed HS-GC-FID method was validated for specificity, repeatability, linearity, accuracy, DL, QL, stability of analyte solution, intermediate precision and robustness.…”

Section: Discussionmentioning

confidence: 99%

“…The DL, QL and recovery results indicated the accuracy and capability of the method to detect ECH at very low levels. The limitations and complexity associated with the reported methods [10–14] for drug substance analysis could be overcome by the proposed method as it is simple, utilizing direct HS extraction and most commonly used FI detection, without any derivatization and SPME fiber extraction. Moreover, the presently developed and validated method is cost-effective and simple to adopt at any pharmaceutical laboratory with moderate run time.…”

Section: Discussionmentioning

confidence: 99%

“…SVH is not official in any pharmacopoeia; however, few reports are available for ECH estimation [10–14]. A GC-FID method was reported for the determination of ECH in workplace atmosphere [10].…”

Section: Introductionmentioning

confidence: 99%

“…al published a headspace solid-phase micro extraction (SPME) procedure followed by GC analysis for ECH estimation in water [13]. GC-MS method for monitoring exposure to ECH by means of quantitative analysis of N -(2,3-dihydroxypropyl)valine adduct in hemoglobin was reported [14]. The published methods evaluated ECH, mostly on clean sample matrices, such as, water and air.…”

Section: Introductionmentioning

confidence: 99%

“…The published methods evaluated ECH, mostly on clean sample matrices, such as, water and air. Additionally, these methods [10–14] utilized derivatization procedures, adduct analysis, SPME fibers, mass and electrochemical detectors. The complexities and limitations of the existing methods and no method reported so far, for the determination of ECH in polymeric drug substance (SVH), prompted to develop a new method.…”

Section: Introductionmentioning

confidence: 99%

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Determination of Residual Epichlorohydrin in Sevelamer Hydrochloride by Static Headspace Gas Chromatography with Flame Ionization Detection

Karthikeyan

2010

Sci. Pharm.

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A sensitive static headspace gas chromatographic method was developed and validated for the determination of residual epichlorohydrin (ECH) in sevelamer hydrochloride (SVH) drug substance. This method utilized a Phenomenex Zebron ZB-WAX GC column, helium as carrier gas with flame ionization detection. The critical experimental parameters, such as, headspace vial incubation time and incubation temperature were studied and optimized. The method was validated as per United States Pharmacopoeia (USP) and International Conference on Harmonization (ICH) guidelines in terms of detection limit (DL), quantitation limit (QL), linearity, precision, accuracy, specificity and robustness. A linear range from 0.30 to 10 μg/mL was obtained with the coefficient of determination (r2) 0.999. The DL and QL of ECH were 0.09 μg/mL and 0.30 μg/mL, respectively. The recovery obtained for ECH was between 91.7 and 96.6%. Also, the specificity of the method was proved through gas chromatography mass spectrometry (GC-MS). This method was applied successfully to determine the content of residual ECH in SVH bulk drug.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Determination of Residual Epichlorohydrin in Sevelamer Hydrochloride by Static Headspace Gas Chromatography with Flame Ionization Detection

Karthikeyan

2010

Sci. Pharm.

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N‐(3‐Chlor‐2‐hydroxypropyl)‐Valin als Hämoglobinaddukt des Epichlorhydrins [Biomonitoring Methods in German language, 2012]

Bader¹,

Rosenberger²,

Tsikas³

et al. 2013

The MAK‐Collection for Occupational Health and Safety

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Veröffentlicht in der Reihe Analytische Methoden zur Prüfung gesundheitsschädlicher Arbeitsstoffe: Analysen in biologischem Material , 20. Lieferung, Ausgabe 2012 Der Artikel enthält folgende Kapitel: Grundlage des Verfahrens Geräte, Chemikalien und Lösungen Geräte Chemikalien Lösungen Vergleichsstandards Probenahme und Probenvorbereitung Herstellung des Erythrozytenlysates Isolierung des Globins Derivatisierung des Globins Instrumentelle Arbeitsbedingungen Gaschromatographische Arbeitsbedingungen Tandem‐Massenspektrometrische Arbeitsbedingungen Analytische Bestimmung Kalibrierung Berechnung der Analysenergebnisse Standardisierung der Messergebnisse und Qualitätssicherung Beurteilung des Verfahrens Präzision Richtigkeit Nachweis‐ und Bestimmungsgrenze Störeinflüsse Diskussion der Methode

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N‐(3‐Chloro‐2‐hydroxypropyl)‐valine in blood as haemoglobin adduct of epichlorohydrin [Biomonitoring Methods, 2013]

Bader¹,

Rosenberger²,

Tsikas³

et al. 2013

The MAK‐Collection for Occupational Health and Safety

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Published in the series Biomonitoring Methods , Vol. 13 (2013) The article contains sections titled: General principles Equipment, chemicals and solutions Equipment Chemicals Solutions Internal standard Calibration standards Specimen collection and sample preparation Preparation of the erythrocyte lysate Isolation of the globin Derivatisation of the globin Operational parameters Operational parameters for gas chromatography Operational parameters for tandem mass spectrometry Analytical determination Calibration Calculation of the analytical result Standardisation and quality control Evaluation of the method Precision Accuracy Detection limit and quantitation limit Sources of error Discussion of the method Appendix

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Biomonitoring of Epichlorohydrin by Hemoglobin Adducts

Cited by 55 publications

References 2 publications

Determination of Residual Epichlorohydrin in Sevelamer Hydrochloride by Static Headspace Gas Chromatography with Flame Ionization Detection

Determination of Residual Epichlorohydrin in Sevelamer Hydrochloride by Static Headspace Gas Chromatography with Flame Ionization Detection

N‐(3‐Chlor‐2‐hydroxypropyl)‐Valin als Hämoglobinaddukt des Epichlorhydrins [Biomonitoring Methods in German language, 2012]

N‐(3‐Chloro‐2‐hydroxypropyl)‐valine in blood as haemoglobin adduct of epichlorohydrin [Biomonitoring Methods, 2013]

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