Nonaqueous capillary electrophoresis method for the enantiomeric purity determination of S-timolol using heptakis(2,3-di-O-methyl-6-O-sulfo)-beta-cyclodextrin: validation using the accuracy profile strategy and estimation of uncertainty

Journal of Chromatography. a
R D MariniMarianne Fillet

Abstract

Nonaqueous capillary electrophoresis (NACE) was successfully applied to the enantiomeric purity determination of S-timolol maleate using heptakis(2,3-di-O-methyl-6-O-sulfo)-beta-cyclodextrin (HDMS-beta-CD) as chiral selector. With a background electrolyte made up of a methanolic solution of 0.75 M formic acid, 30 mM potassium camphorsulfonate and containing 30 mM HDMS-beta-CD, the determination of 0.1% of R-timolol in S-timolol could be performed with an enantiomeric resolution of 8.5. Pyridoxine was selected as internal standard. The NACE method was then fully validated by applying a novel strategy using accuracy profiles. It is based on beta-expectation tolerance intervals for the total measurement error which includes trueness and intermediate precision. The uncertainty of measurements derived from beta-expectation tolerance intervals was estimated at each concentration level of the validation standards. To confirm the suitability of the developed and validated method, several real samples of S-timolol maleate containing R-timolol maleate at different concentrations were analysed and the results were compared to those obtained by liquid chromatography.

Citations

Jan 5, 2016·Journal of Pharmaceutical and Biomedical Analysis·Katarzyna MichalskaElżbieta Bednarek
Aug 20, 2010·Journal of Pharmaceutical and Biomedical Analysis·R D MariniS Rudaz
Jul 14, 2007·Journal of Pharmaceutical and Biomedical Analysis·C BodsonL Delattre
May 24, 2014·Electrophoresis·Pavel RezankaDavid Sýkora
Apr 19, 2008·Electrophoresis·Zoltán JuvanczLajos Szente
Dec 25, 2008·Electrophoresis·Laurent Geiser, Jean-Luc Veuthey
Jun 12, 2009·Electrophoresis·Bezhan Chankvetadze
Aug 8, 2021·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Gabriel HancuSandra Furlanetto
Jun 20, 2013·Analytical Chemistry·E RozetPh Hubert
May 22, 2007·Analytical Chemistry·R K Gilpin, C S Gilpin

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