Development of micellar electrokinetic chromatography method for the determination of three defined impurities in indomethacin

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11160%2F18%3A10382324" target="_blank" >RIV/00216208:11160/18:10382324 - isvavai.cz</a>

Result on the web

<a href="http://onlinelibrary.wiley.com/doi/10.1002/elps.201800080" target="_blank" >http://onlinelibrary.wiley.com/doi/10.1002/elps.201800080</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1002/elps.201800080" target="_blank" >10.1002/elps.201800080</a>

Result language

angličtina

Original language name

Development of micellar electrokinetic chromatography method for the determination of three defined impurities in indomethacin

Original language description

A micellar electrokinetic chromatography method for the determination of indomethacin impurities (4-chlorobenzoic acid, 5-methoxy-2-methyl-3-indoleacetic acid, and 3,4-dichloroindomethacin) has been developed. A 64.5/56-cm fused silica 50 mu m id capillary with extended light path (150 mu m id) detection window was used. Internal standard was 1-naphthylacetic acid. The analytes were separated at 30 kV with DAD detection at 224 nm. A central composite face-centered design was applied for the optimization of the separation conditions. The effect of SDS concentration, content of methanol, concentration of phosphate buffer, and pH of the buffer were studied at three levels. The optimized background electrolyte was 20 mmol/L phosphate buffer (pH 7.57) containing 58 mmol/L SDS and 0% MeOH. Sufficient resolution of all compounds with Rs &gt;= 3.5 was achieved within 10 min. The method was validated for a range of 1.25-80 mu g/mL of each impurity corresponding to 0.05-3.2% relative to the concentration of indomethacin (2.5 mg/mL). The calibration curves were rectilinear with correlation coefficients r(2) exceeding 0.9994. The lower limit of quantification was 0.05% or 1.25 mu g/mL that complies with the reporting limits regarding the ICH Q3A guideline. The method was applied to purity assay of indomethacin in both bulk drug and gel.

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

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OECD FORD branch

30104 - Pharmacology and pharmacy

Project

<a href="/en/project/EF15_003%2F0000465" target="_blank" >EF15_003/0000465: Establishment of Specialized Team for Advanced Research on Separation Science</a><br>

Continuities

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)<br>S - Specificky vyzkum na vysokych skolach<br>I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2018

Confidentiality

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

Name of the periodical

Electrophoresis

ISSN

0173-0835

e-ISSN

—

Volume of the periodical

39

Issue of the periodical within the volume

20

Country of publishing house

DE - GERMANY

Number of pages

8

Pages from-to

2550-2557

UT code for WoS article

000447441600007

EID of the result in the Scopus database

2-s2.0-85054766982