Ziprasidone (5-(2-(4-(1,2-benzisothiazol-3-yl)piperazinyl)ethyl)-6-chloro-1,3-dihydro-2(1H)-indol-2-one hydrochloride monohydrate (3)) with the chemical formula C₂₁H₂₁ClN₄OS* HCl*H₂O) is a new antipsychotic with combined dopamine and serotonin receptor antagonist activity. Clinical trials suggest that the drug is an effective antipsychotic in schizophrenia and schizoaffective disorder with a beneficial effect on negative symptoms and symptoms of depression.

The monohydrate hydrochloride (3) was obtained from the appropriate base prepared in condensation reaction of starting materials 1 and 2. For the final product purity determination a simple analytical method was developed.

High-Performance Liquid Chromatography (HPLC) is a simple analytical technique for the separation and determination of organic analytes in pharmaceutical samples.

The optimalization of the reversed phase high-performance liquid chromatographic separation of ziprasidone and starting materials is described. This method was successfully applied to the analysis of compound purity. The method is sufficiently simple and rapid for the quality assurance of this type of compounds. The peaks in the chromatograms of a mixture were identified based on the retention times of isolated components injected separately.

The X-Ray powder diffraction method (XRPD) and infrared spectroscopy (IR) were used to identify and characterize the samples of substance and tablets of Ziprasidone toward the polymorphic form.

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