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Talanta. 2016 May 1;151:75-82. doi: 10.1016/j.talanta.2016.01.022. Epub 2016 Jan 13.

Propylene carbonate quantification by its derivative 3,5-diacetyl-1,4-dihydro-2,6-lutidine.

Author information

1
Department of Pharmaceutics, Pharmaceutical Institute, University of Bonn, Gerhard-Domagk-Str. 3, 53121 Bonn, Germany. Electronic address: daris.grizic@uni-bonn.de.
2
Pharmaceutical Chemistry I, Pharmaceutical Institute, University of Bonn, Brühler Str. 7, 53119 Bonn, Germany.
3
Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Sarajevo, Zmaja od Bosne 8, 71 000 Sarajevo, Bosnia and Herzegovina.
4
Department of Pharmaceutics, Pharmaceutical Institute, University of Bonn, Gerhard-Domagk-Str. 3, 53121 Bonn, Germany; FDE (EA4267), University of Dijon/Franche-Comté, 19 rue Ambroise Paré, 25030 Besançon Cedex, France. Electronic address: alf.lamprecht@uni-bonn.de.

Abstract

Propylene carbonate (PC) is a non-toxic solvent currently used in various pharmaceutical formulations. Consequently, a simple, cost-effective and most accurate analytical method for the quantification of this optical inert solvent is of major interest. Based on a consecutive three-step reaction 3,5-diacetyl-1,4-dihydro-2,6-lutidine was obtained from PC and used for quantification by either UV and fluorescent detection. Data were compared with results from LC-ESI-MS as a reference method. After using Mandel's test for linearity assessment of the calibration curves, linear fitting was used for LC-ESI-MS and spectrofluorimetry, while a polynomial 3rd order curve fitting was used for spectrophotometry. High intra- and inter-day precision as well as high accuracy were confirmed for all three analytical methods (spectrophotometry, spectrofluorimetry and LC-ESI-MS). The comparison of all three methods was assessed using correlation coefficients and Bland-Altman plots, both showing satisfying results with a high degree of agreement. The new method confirmed its applicability for PC quantification in two formulations, namely a PC-enriched cream and polyester microimplants. This new quantification method for PC is a reliable alternative to highly sophisticated chromatographic methods.

KEYWORDS:

Dihydropyridine condensation; LC-ESI-MS; Propylene carbonate; Residual solvent quantification

PMID:
26946012
DOI:
10.1016/j.talanta.2016.01.022
[Indexed for MEDLINE]

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