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.keywords | degradation, impurities, N-pyrrolylcarboxylic acid, RP-HPLC, validation | |
creativework.publisher | Pensoft Publishers | en |
dc.contributor.author | Maslarska V. | |
dc.contributor.author | Bozhanov S. | |
dc.contributor.author | Vladimirova S. | |
dc.contributor.author | Peikova L. | |
dc.contributor.author | Tzankova D. | |
dc.contributor.author | Georgieva M. | |
dc.date.accessioned | 2024-07-10T14:27:05Z | |
dc.date.accessioned | 2024-07-10T14:50:08Z | |
dc.date.available | 2024-07-10T14:27:05Z | |
dc.date.available | 2024-07-10T14:50:08Z | |
dc.date.issued | 2022-01-01 | |
dc.description.abstract | A 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.doi | 10.3897/pharmacia.69.e80843 | |
dc.identifier.issn | 0428-0296 | |
dc.identifier.scopus | SCOPUS_ID:85129653190 | en |
dc.identifier.uri | https://rlib.uctm.edu/handle/123456789/716 | |
dc.language.iso | en | |
dc.source.uri | https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85129653190&origin=inward | |
dc.title | 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 | |
dc.type | Article | |
oaire.citation.issue | 2 | |
oaire.citation.volume | 69 |