Determination of the enantiomer and positional isomer impurities in atomoxetine hydrochloride with liquid chromatography using polysaccharide chiral stationary phases

Journal of Pharmaceutical and Biomedical Analysis
Jane A SellersPeter F Gavin

Abstract

A normal-phase isocratic chiral liquid chromatographic method has been developed and validated for atomoxetine hydrochloride. In addition to the S-enantiomer of atomoxetine, the conditions separate both para and meta positional isomers and the phenyl des-methyl analog. Method development strategies included (a) evaluation of polysaccharide-based chiral stationary phases with nonaqueous mobile phases, (b) the use of an octyl stationary phase with a sulfated-beta-cyclodextrin mobile phase additive, and (c) capillary electrophoresis using a single isomer heptakis-6-sulfato-beta-cyclodextrin modifier. All three approaches yielded acceptable conditions for the separation of atomoxetine from related molecules with the former fully validated and the latter two held as alternatives if needed. The final method conditions employing a Chiralcel OD-H column and mobile phase of hexane/IPA/DEA/TFA (85/15/0.15/0.2, v/v/v/v) at 1.0 mL/min have been fully validated with acceptable specificity, linearity, accuracy, repeatability, intermediate precision and quantitation limit.

References

Feb 17, 1998·Journal of Chromatography. a·J H Luong, A L Nguyen
Feb 24, 2001·Journal of Chromatography. a·D Hindocha, N W Smith
Feb 24, 2001·Journal of Chromatography. a·N M MaierW Lindner

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Citations

Dec 31, 2016·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Tohru ShibataKazuyoshi Ueda
Sep 12, 2006·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Muzaffar KhanRajasekhar Reddy
Dec 18, 2007·Journal of Pharmaceutical and Biomedical Analysis·Peter F Gavin, Bernard A Olsen
May 22, 2007·Analytical Chemistry·R K Gilpin, C S Gilpin

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