title: Determination of Magnesium Valproate and Its Process Related Impurities by Ultraperformance Liquid Chromatography.
abstract: 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 C18 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.
authors.affiliation: National Facility for Drug Discovery through NCEs Development & Instrumentation Support to SMPEs, Department of Chemistry, Saurashtra University, Rajkot, Gujarat 360005, India.
authors.forename: Rakshit
authors.identifier: 0000-0003-2174-3869
authors.initials: R
authors.lastname: Thakkar
authors.affiliation: National Facility for Drug Discovery through NCEs Development & Instrumentation Support to SMPEs, Department of Chemistry, Saurashtra University, Rajkot, Gujarat 360005, India.
authors.forename: Hitesh
authors.initials: H
authors.lastname: Saravaia
authors.affiliation: National Facility for Drug Discovery through NCEs Development & Instrumentation Support to SMPEs, Department of Chemistry, Saurashtra University, Rajkot, Gujarat 360005, India.
authors.forename: Madhavi
authors.initials: M
authors.lastname: Patel
authors.affiliation: National Facility for Drug Discovery through NCEs Development & Instrumentation Support to SMPEs, Department of Chemistry, Saurashtra University, Rajkot, Gujarat 360005, India.
authors.forename: Anamik
authors.initials: A
authors.lastname: Shah