Development of rapid and robust stability-indicating method for analysis of ziprasidone (hydrochloride and freebase) as drug substance and in medicines by UPLC.

ABSTRACT

Ultra Performance Liquid Chromatography (UPLC) was employed to develop a rapid and robust method for the analysis of ziprasidone, both as a drug substance and in the final dosage forms. The application of this method in stability analyses was verified. Tests were carried out according to ICH/FDA guidelines, European Pharmacopeia, and United States Pharmacopeia rules, which take into account factors such as specificity, linearity, accuracy, and precision. Separation was performed on an Acquity UPLC BEH phenyl 1.7-microm column with a simple mobile phase, consisting of acetonitrile and water adjusted to pH 2.0 with ortho-phosphoric acid. Using this mobile phase and gradient elution, the separation was completed within 5 min. This method is very sensitive, and allows performing simultaneous identification, assay, and determination of impurities and related substances in one injection.