Quantitation of poloxamers in pharmaceutical formulations using size exclusion chromatography and colorimetric methods

Journal of Pharmaceutical and Biomedical Analysis
Yun MaoEric W Tsai

Abstract

Poloxamers have been used as functional excipients in pharmaceutical products. They function as surfactants, emulsifying agents, solubilizing agents, dispersing agents, and in vivo absorbance enhancer. Despite their wide range of applications, limited analytical techniques have been reported in literature for characterizing poloxamers and few are targeted to quantify poloxamer contents in formulations with desired sensitivity and accuracy. In this paper, two distinct analytical methods for quantifying low levels of poloxamers in pharmaceutical formulations have been developed and optimized: a colorimetric method and a size exclusion chromatography method. The colorimetric method is based on the formation of a colored complex between poloxamers and cobalt(II) thiocyanate in aqueous medium, which has a maximum UV absorbance at 624 nm. The feasibility of this method is product specific. In this report, adequate specificity and sensitivity was demonstrated for only one of the several products tested. The size exclusion chromatography (SEC) method utilizes size exclusion columns with THF as mobile phase and refractive index detection. The SEC method provides a limit of quantitation (LOQ) of 0.005 mg/mL (0.0005%, w/w) and at least th...Continue Reading

References

May 10, 2001·Rapid Communications in Mass Spectrometry : RCM·Z TakátsL Hegedüs
Jan 22, 2003·Advanced Drug Delivery Reviews·Alexander V KabanovDonald W Miller
Nov 18, 2005·Journal of Colloid and Interface Science·Søren HvidtWalther Batsberg

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Citations

Nov 11, 2006·Pharmaceutical Research·Gilles DumortierJean Claude Chaumeil
Jun 6, 2009·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Yu LiuWei-yue Lu
Jul 5, 2008·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·S CafaggiG Bignardi
Oct 20, 2015·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Lorena García-GonzálezAdriana Ganem

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