Desenvolvimento de metodologia analítica para a validação do IFA paracetamol pela técnica de Cromatografia Líquida de Alta Eficiência (CLAE)
The present study developed and validated an analytical method for the Active Pharmaceutical Ingredient (API) paracetamol, based on the requirements of ANVISA's RDC No. 166/2017. The process encompassed steps from solution preparation to analysis using high-performance liquid chromatography. Pa...
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| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2024 |
| País: | Brasil |
| Institución: | Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS) |
| Repositorio: | Repositório Institucional PUCRS |
| Idioma: | portugués |
| OAI Identifier: | oai:meriva.pucrs.br:10923/27013 |
| Acceso en línea: | https://hdl.handle.net/10923/27013 |
| Access Level: | acceso abierto |
| Palabra clave: | CONTAMINANTES EMERGENTES PARACETAMOL CROMATOGRAFIA LÍQUIDA EMERGING CONTAMINANTS ACETAMINOPHEN LIQUID CHROMATOGRAPHY |
| Sumario: | The present study developed and validated an analytical method for the Active Pharmaceutical Ingredient (API) paracetamol, based on the requirements of ANVISA's RDC No. 166/2017. The process encompassed steps from solution preparation to analysis using high-performance liquid chromatography. Parameters such as selectivity, linearity, precision, accuracy, and robustness were evaluated. Selectivity was demonstrated through forced degradation, confirming that the method is free from interference by impurities or degradation products. Linearity was validated with a correlation coefficient greater than 0.990, ensuring the reliability of the analytical curve. Precision was verified through repeatability and intermediate precision, both within acceptable limits. Accuracy showed a recovery rate ranging from 90% to 107%, while robustness demonstrated that the method tolerates small operational variations. The results met the acceptance criteria, confirming the method’s validity for use in various quantification applications for this pharmaceutical compound. |
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