Development and validation of a LC-UV Method Applied to the Quality Control of Ursodeoxycholic Acid in Raw Material and Pharmaceutical Formulations
A simple, fast, and sensitive HPLC method with UV detection has been developed for the quantitation of ursodeoxycholic acid (UDCA) in raw material and pharmaceutical formulation (suspension). Cromatographic conditions were: Symmetry-C18 column (150 mm x 4.6 mm, id; particle size 5 µm), 40 ˚C, 100 µL...
| Autores: | , , , , , |
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| Formato: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2017 |
| País: | Argentina |
| Recursos: | Consejo Nacional de Investigaciones Científicas y Técnicas |
| Repositorio: | CONICET Digital (CONICET) |
| Idioma: | inglés |
| OAI Identifier: | oai:ri.conicet.gov.ar:11336/156558 |
| Acesso em linha: | http://hdl.handle.net/11336/156558 |
| Access Level: | acceso abierto |
| Palavra-chave: | URSODEOXICHOLIC ACID HPLC-UV QUALITY CONTROL PHARMACEUTICAL FORMULATION RAW MATERIAL https://purl.org/becyt/ford/1.4 https://purl.org/becyt/ford/1 |
| Resumo: | A simple, fast, and sensitive HPLC method with UV detection has been developed for the quantitation of ursodeoxycholic acid (UDCA) in raw material and pharmaceutical formulation (suspension). Cromatographic conditions were: Symmetry-C18 column (150 mm x 4.6 mm, id; particle size 5 µm), 40 ˚C, 100 µL injection volume and UV detection at 200 nm. The flow rate was 1 ml/min using acetonitrile - phosphoric acid (pH 3.0; 0.15mM) (48:52) as mobile phase. The method was validated according to international guidelines (ICH guidelines) for specificity, linearity, LOD, LOQ, precision, accuracy, and robustness. The HPLC-UV method was found to be suitable for the quality control of UDCA raw material and pharmaceutical formulation. |
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