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

Abstract

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 fi rst method was based on reversed-phase high-performance liquid chromatography (HPLC), on a Lichrosorb RP C(18) column using water:acetonitrile:phosphoric acid (76:24:0.5 v/v/v) as the mobile phase at a fl ow rate of 1.5 mL min(-1) at ambient temperature. Quantification was achieved with UV detection at 229 nm over a concentration range of 10-500 micro g 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(254) using choloroform:methanol:glacial acetic acid (75:5:4.5 v/v/v) as the mobile phase, over a concentration range of 1-10 micro g per spot and mean percentage recovery of 99.26 +/- 0.39. Both methods were applied successfully to laboratory prepared mixtures and pharmaceutical capsules.

Influence of selected mobile phase properties on the TLC retention behavior of ziprasidone and its impurities

“…In seeking for the best mobile phase composition to separate ziprasidone and its five impurities, silica gel was selected as stationary phase, and mixture of chloroform-methanol-glacial acetic acid (75:5:4.5, v/v/v), previously described in the literature, [15] was used as mobile phase. This mobile phase enabled separation of impurities I and II from ziprasidone, impurity III remained at the start line, whereas impurities IV and V co-eluated with active substance.…”

Rapid liquid chromatography–tandem mass spectrometry method for quantification of ziprasidone in human plasma

“…Methods used include high-performance liquid chromatography (HPLC) with ultraviolet detection (Janiszwewski et al, 1995;Sachse et al, 2005), HPLC with fluorescence detection (Suckow et al, 2004), and by mass spectrometry (MS;Janiszwewski et al, 1998). Recently, we reported a stability-indicating HPLC method for ZIP and applied it to the determination of this compound in bulk powder and in pharmaceutical formulations (El-Sherif et al, 2004).…”

Development and validation of stability indicating UPLC assay method for ziprasidone active pharma ingredient

“…[1,2] Ziprasidone is most effective in schizophrenia, a chronic illness that requires lifelong treatment spread over approximately 1% of the world's population. [3,4] Literature survey for ziprasidone revealed several analytical methods based on different techniques, viz, LC-MS [5][6][7] assay for their quantification in plasma and brain, high performance liquid chromatography (HPLC) [8][9][10] method for simultaneous determination of ziprasidone in capsule formulation, and HPLC-UV [11] methods for determination ziprasidone in human plasma and urine, LC [12] with fluorescence for determination of plasma ziprasidone, and capillary zone electrophoresis [13] for determination of ziprasidone in pharmaceutical formulations.…”