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Determination of Magnesium Valproate and Its Process Related Impurities by Ultraperformance Liquid Chromatography

A selective ultraperformance liquid chromatographic (UPLC) method for the determination of magnesium valproate and its process related impurities has been developed. The method includes reversed-phase Acquity BEH C(18) column with 100 mm × 2.1 mm i.d. and 1.7 µ particle size. The mobile phase consis...

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Detalles Bibliográficos
Autores principales: Thakkar, Rakshit, Saravaia, Hitesh, Patel, Madhavi, Shah, Anamik
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Hindawi Publishing Corporation 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4897345/
https://www.ncbi.nlm.nih.gov/pubmed/27355082
http://dx.doi.org/10.1155/2014/412704
Descripción
Sumario:A selective ultraperformance liquid chromatographic (UPLC) method for the determination of magnesium valproate and its process related impurities has been developed. The method includes reversed-phase Acquity BEH C(18) column with 100 mm × 2.1 mm i.d. and 1.7 µ particle size. The mobile phase consists of acetonitrile and 5 mM ammonium dihydrogen orthophosphate with pH = 3.0 at 45 : 55 isocratic elution. The flow rate was set at 0.3 mL/min and UV detection was performed at 215 nm. A system suitability test (SST) was developed to govern the quality of the separation. The developed method has been validated further with respect to linearity, accuracy, precision, selectivity, LOD, LOQ, and robustness. Different batches of samples were examined using this method; the method proved to be successful when applied to analyze a marketed magnesium valproate formulation.