Development and validation of an RP-HPLC method for analysis of 2-(5-(4-chlorophenyl)-3-(ethoxycarbonyl)-2-methyl-1H-pyrrol-1-yl)propanoic acid and its impurities under different pH

creativework.keywordsdegradation, impurities, N-pyrrolylcarboxylic acid, RP-HPLC, validation
creativework.publisherPensoft Publishersen
dc.contributor.authorMaslarska V.
dc.contributor.authorBozhanov S.
dc.contributor.authorVladimirova S.
dc.contributor.authorPeikova L.
dc.contributor.authorTzankova D.
dc.contributor.authorGeorgieva M.
dc.date.accessioned2024-07-10T14:27:05Z
dc.date.accessioned2024-07-10T14:50:08Z
dc.date.available2024-07-10T14:27:05Z
dc.date.available2024-07-10T14:50:08Z
dc.date.issued2022-01-01
dc.description.abstractA simple, fast and selective stability indicating RP-HPLC method was applied for following the degradation and appearance of impurities of previously synthesized 2-(5-(4-chlorophenyl)-3-(ethoxycarbonyl)-2-methyl-1H-pyrrol-1-yl)propanoic acid. The chromatographic separation was achieved on a C18 column (150x4 mm i.d., 5 µm) using a mobile phase consisting of Acetonitrile: Phosphate buffer, pH=3, (50:50% v/v) with isocratic elution at a flow rate of 1.0 mL min-1 and temperature of the column of 30 °C applying a UV/VIS detector at 225 nm. The method was validated according to the ICH guidelines. A process related impurity was determined at pH 9.0 corresponding to ethyl 2-acetyl-4-(4-chlorophenyl)-4-oxobutanoate. No change in the structure was detected at pH = 7.4.
dc.identifier.doi10.3897/pharmacia.69.e80843
dc.identifier.issn0428-0296
dc.identifier.scopusSCOPUS_ID:85129653190en
dc.identifier.urihttps://rlib.uctm.edu/handle/123456789/716
dc.language.isoen
dc.source.urihttps://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85129653190&origin=inward
dc.titleDevelopment and validation of an RP-HPLC method for analysis of 2-(5-(4-chlorophenyl)-3-(ethoxycarbonyl)-2-methyl-1H-pyrrol-1-yl)propanoic acid and its impurities under different pH
dc.typeArticle
oaire.citation.issue2
oaire.citation.volume69
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