Stability indicating reversed-phase high-performance liquid chromatographic and thin layer densitometric methods for the determination of ziprasidone in bulk powder and in pharmaceutical formulations

Two sensitive and reproducible methods were developed and validated for the determination of ziprasidone (ZIP) in the presence of its degradation products in pure form and in pharmaceutical formulations. The first method was based on reversed-phase high-performance liquid chromatography (HPLC), on a Lichrosorb RP C, column using water:acetonitrile:phosphoric acid (76:24:0.5 v/v/v) as the mobile phase at a flow rate of 1.5 mL min(-1) at ambient temperature. Quantification was achieved with UV detection at 229 run over a concentration range of 10-500 mug mL(-1) with mean percentage recovery of 99.71 +/- 0.55. The method retained its accuracy in presence of up to 90% of ZIP degradation products. The second method was based on TLC separation of ZIP from its degradation products followed by densitometric measurement of the intact drug spot at 247 nm. The separation was carried out on aluminium sheet of silica gel 60 F,, using choloroform:methanol:glacial acetic acid (75:5:4.5 v/v/v) as the mobile phase, over a concentration range of 1-10 mug per spot and mean percentage recovery of 99.26 +/- 0.39. Both methods were applied successfully to laboratory prepared mixtures and pharmaceutical capsules. Copyright (C) 2003 John Wiley Sons, Ltd.