Is supercritical fluid chromatography hyphenated to massspectrometry suitable for the quality control of vitamin D3 oilyformulations?

Andri, Bertyl; Dispas, Amandine; Klinkenberg, Régis; Streel, Bruno; Marini Djang'Eing'A, Roland; Ziemons, Eric; Hubert, Philippe

doi:10.1016/j.chroma.2017.07.057

Article (Scientific journals)

Is supercritical fluid chromatography hyphenated to massspectrometry suitable for the quality control of vitamin D3 oilyformulations?

Andri, Bertyl; Dispas, Amandine; Klinkenberg, Régis et al.

2017 • In Journal of Chromatography. A, 1515, p. 209-217

Peer Reviewed verified by ORBi

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https://hdl.handle.net/2268/214449

DOI
10.1016/j.chroma.2017.07.057

PubMed
28811100

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Keywords :

SFC-MS; Green analytical chemistry; Vitamin D3; Method validation; Accuracy profile

Abstract :

[en] Nowadays, many efforts are devoted to improve analytical methods regarding efficiency, analysis timeand greenness. In this context, Supercritical Fluid Chromatography (SFC) is often regarded as a goodalternative over Normal Phase Liquid Chromatography (NPLC). Indeed, modern SFC separations arefast, efficient with suitable quantitative performances. Moreover, the hyphenation of SFC to mass spec-trometry (MS) provides additional gains in specificity and sensitivity. The present work aims at thedetermination of vitamin D3 by SFC-MS for routine Quality Control (QC) of medicines specifically. Basedon the chromatographic parameters previously defined in SFC-UV by Design of Experiments (DoE) andDesign Space methodology, the method was adapted to work under isopycnic conditions ensuring a base-line separation of the compounds. Afterwards, the response provided by the MS detector was optimizedby means of DoE methodology associated to desirability functions. Using these optimal MS parameters,quantitative performances of the SFC-MS method were challenged by means of total error approachmethod validation. The resulting accuracy profile demonstrated the full validity of the SFC-MS method. It was indeed possible to meet the specification established by the European Medicines Agency (EMA) (i.e. 95.0 − 105.0% of the API content) for a dosing range corresponding to at least 70.0-130.0% of theAPI content. These results highlight the possibility to use SFC-MS for the QC of medicine and obviouslysupport the switch to greener analytical methods.

Research Center/Unit :

CIRM - Centre Interdisciplinaire de Recherche sur le Médicament - ULiège

Disciplines :

Pharmacy, pharmacology & toxicology

Author, co-author :

Andri, Bertyl ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique

Dispas, Amandine ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique

Klinkenberg, Régis; Galephar Research Center M/F

Streel, Bruno; Galephar Research Center M/F

Marini Djang'Eing'A, Roland ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique

Ziemons, Eric ; Université de Liège - ULiège > Département de pharmacie > Département de pharmacie

Hubert, Philippe ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique

Language :

English

Title :

Is supercritical fluid chromatography hyphenated to massspectrometry suitable for the quality control of vitamin D3 oilyformulations?

Publication date :

27 July 2017

Journal title :

Journal of Chromatography. A

ISSN :

0021-9673

eISSN :

1873-3778

Publisher :

Elsevier Science, Amsterdam, Netherlands

Volume :

1515

Pages :

209-217

Peer reviewed :

Peer Reviewed verified by ORBi

Additional URL :

http://dx.doi.org/10.1016/j.chroma.2017.07.057

Name of the research project :

First International In-SCrit n°1217860

Funders :

DGTRE - Région wallonne. Direction générale des Technologies, de la Recherche et de l'Énergie

Available on ORBi :

since 21 September 2017

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