title: Simultaneous determination of the counter ion and possible impurity from the synthetic route in the pharmaceutical substance prasugrel hydrochloride.
abstract: A fast and selective capillary electrophoresis method was developed and validated for the simultaneous determination of the hydrochloride and acetic acid content in prasugrel hydrochloride. Because of the poor chromophore, the indirect detection was chosen. Among different compositions studied as the background electrolyte, the pyromellitic acid with diethylamine (DEA) and myristyltrimethylammonium bromide (TTAB) was chosen. During the validation the specificity, linearity, accuracy, precision, range, and stability of the sample solution were confirmed. The results indicate that the method is suitable for the determination of the counter ion and impurity from the synthetic route of the pharmaceutical drug substance in the same assay.
authors.affiliation: Pharmaceutical Research Institute, Rydygiera 8, 01-791 Warsaw, Poland. Electronic address: w.maruszak@ifarm.eu.
authors.forename: Wioleta
authors.initials: W
authors.lastname: Maruszak
authors.affiliation: Pharmaceutical Research Institute, Rydygiera 8, 01-791 Warsaw, Poland.
authors.forename: Marcin
authors.initials: M
authors.lastname: Cybulski
mesh_terms: D019342:Acetic Acid / Q000032:analysis; D004340:Drug Contamination / Q000517:prevention & control*; D006851:Hydrochloric Acid / Q000032:analysis; D007477:Ions; D015394:Molecular Structure; D010879:Piperazines / Q000032:analysis* / Q000737:chemistry / Q000592:standards*; D000068799:Prasugrel Hydrochloride; D012680:Sensitivity and Specificity; D013678:Technology, Pharmaceutical / Q000379:methods*; D013876:Thiophenes / Q000032:analysis* / Q000737:chemistry / Q000592:standards*
chemical_list: D007477:Ions; D010879:Piperazines; D013876:Thiophenes; D000068799:Prasugrel Hydrochloride; D019342:Acetic Acid; D006851:Hydrochloric Acid
keywords: Capillary electrophoresis; Counter ion; Impurity determination; Prasugrel hydrochloride; Validation