title: Development and validation of an HPLC method for determination of ziprasidone and its impurities in pharmaceutical dosage forms.
abstract: Ziprasidone is known as a novel "atypical" or "second-generation" antipsychotic drug. A sensitive and reproducible method was developed and validated for determination of ziprasidone and its major impurities, which are significantly different in polarity. The separation is performed on a Waters Spherisorb octadecylsilyl 1 column (5.0 microm particle size, 250 x 4.6 mm id) using a gradient with mobile phase A [buffer-acetonitrile (80+20, v/v)] and mobile phase B [buffer-acetonitrile (10+90, v/v)] at a working temperature of 25 degrees C. The buffer was 0.05 M KH2PO4 solution with an addition of 10 mL triethylamine/L solution, adjusted to pH 2.5 with orthophosphoric acid. The flow rate was 1.5 mL/min, and the eluate was monitored at 250 nm using a diode array detector. Optimization of the experimental conditions was performed using partial least squares regression, for which four factors were selected for optimization: buffer concentration, buffer pH, triethylamine concentration, and temperature. The proposed validated method is convenient and reliable for the assay and purity control in both raw materials and dosage forms.
authors.affiliation: Medicines and Medical Devices Agency of Serbia, Belgrade, Serbia.
authors.forename: Marija
authors.initials: M
authors.lastname: Pavlovic
authors.forename: Marija
authors.initials: M
authors.lastname: Malesevic
authors.forename: Katarina
authors.initials: K
authors.lastname: Nikolic
authors.forename: Danica
authors.initials: D
authors.lastname: Agbaba
mesh_terms: D014150:Antipsychotic Agents / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004304:Dosage Forms; D004340:Drug Contamination; D015394:Molecular Structure; D010879:Piperazines / Q000737:chemistry*; D015203:Reproducibility of Results; D013844:Thiazoles / Q000737:chemistry*
chemical_list: D014150:Antipsychotic Agents; D004304:Dosage Forms; D010879:Piperazines; D013844:Thiazoles; C092292:ziprasidone