High Performance Liquid Chromatographic Estimation of Ziprasidone in Human Serum

A simple, sensitive and rapid high performance liquid chromatography method with fluorescence detection (Ex: 320 nm and Em: 410nm)was developed and validated for the quantification of Ziprasidoin human serum. Following a single-step liquid–liquid extraction with methyl-tert-butyl ether,the analyte and internal standard (Prazosin) were separated using an isocratic mobile phase of 10mM Potassium dihydrogen phosphate buffer (pH: 2.5): Acetonitrile (70: 30)on reverse phase C-18 Hypersil gold, 150 X 4.6 mm, 5 μ. The lower limit of quantitation was1.5 ng/mL,with a relative standard deviation of less than 20%. A linear range of 1.5 ng/mL to 200 ng/mL was established. This HPLC method was validated with between and within-batch precision of 3.0-7.0% and 1.7-12.5%respectively. Thebetween and within batch accuracy was 96.2-99.4 % and 93.5-100.2%, respectively. Frequently co-administered drugs did not interferewith the described methodology. Stability of Ziprasidone in serum was >90%, with no evidence of degradation during sample processing (autosampler) and70 days storage in a freezer (-65+5°C). This validated method is sensitive, simple and repeatable enough to be used in pharmacokinetic studies.