Using single-isomer octa(6-O-sulfo)-gamma-cyclodextrin for fast capillary zone electrophoretic enantioseparation of pindolol: Determination of complexation constants, software-assisted optimization, and method validation

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11310%2F18%3A10379256" target="_blank" >RIV/00216208:11310/18:10379256 - isvavai.cz</a>

Result on the web

<a href="https://doi.org/10.1016/j.chroma.2018.07.020" target="_blank" >https://doi.org/10.1016/j.chroma.2018.07.020</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.chroma.2018.07.020" target="_blank" >10.1016/j.chroma.2018.07.020</a>

Result language

angličtina

Original language name

Using single-isomer octa(6-O-sulfo)-gamma-cyclodextrin for fast capillary zone electrophoretic enantioseparation of pindolol: Determination of complexation constants, software-assisted optimization, and method validation

Original language description

The present study describes a rapid and effective capillary electrophoresis (CE) method for the enantioseparation of pindolol using single-isomer octa(6-O-sulfo)-gamma-cyclodextrin. The complexation parameters were determined under neutral and high pH conditions to identify optimal separation conditions using a theoretical model. Baseline separation of pindolol enantiomers was achieved within 6 min in a sodium/MOPS buffer, pH 7.2, with a selector concentration of 6 mM. The method was validated according to the ICH guidelines using imidazole as an internal standard. Low limits of detection and quantification were found, specifically 1.2 mu g/mL and 4 mu g/mL (0.6 mu g/mL and 2 mu g/mL per enantiomer), respectively. The calibration curves showed good linearity, with a coefficient of determination R-2 &gt;= 0.999 over a 5 - 55 mu g/mL concentration range and over a 50 - 300 mu g/mL concentration range of the racemic mixture. The relative standard deviations (%RSD) of intra-day and inter-day precision were lower than 8% at LOQ level, lower than 3% at 50 mu g/mL level and lower than 1.5% at 300 mu g/mL level. Accuracy ranged from 95 to 103% (106% at LOQ level). The proposed method was successfully tested on a medical formulation of Visken (R) Sandoz intravenous solution and Visken (R) Teofarma pills for oral use.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

10406 - Analytical chemistry

Project

<a href="/en/project/GA16-05942S" target="_blank" >GA16-05942S: Gradient chromatofocusing and isoelectric focusing - tools for separation of proteins</a><br>

Continuities

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Publication year

2018

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Journal of Chromatography A

ISSN

0021-9673

e-ISSN

—

Volume of the periodical

1568

Issue of the periodical within the volume

September

Country of publishing house

NL - THE KINGDOM OF THE NETHERLANDS

Number of pages

8

Pages from-to

214-221

UT code for WoS article

000443669600023

EID of the result in the Scopus database

2-s2.0-85049580456