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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
Author(s) -
ElSherif Zeinab A.,
ElZeany Badr,
ElHoussini Ola M.,
Rashed Mohamed S.,
AboulEnein Hassan Y.
Publication year - 2004
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.299
Subject(s) - chemistry , chromatography , acetic acid , phosphoric acid , silica gel , methanol , high performance liquid chromatography , pharmaceutical formulation , dosage form , degradation (telecommunications) , forced degradation , phase (matter) , ziprasidone , reversed phase chromatography , organic chemistry , telecommunications , schizophrenia (object oriented programming) , clozapine , computer science , programming language
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 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 ow rate of 1.5 mL min −1 at ambient temperature. Quantication was achieved with UV detection at 229 nm over a concentration range of 10–500 µg 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 µg per spot and mean percentage recovery of 99.26 ± 0.39. Both methods were applied successfully to laboratory prepared mixtures and pharmaceutical capsules. Copyright © 2003 John Wiley & Sons, Ltd.