Abstract
A significant percentage of psychiatric patients are treated with antipsychotic drug in the clinic. Thus, it is advantageous to use a rapid and reliable assay that is suitable for determination of antipsychotic drug in a single run. A simple and sensitive HPLC method was developed and validated for quantification of Ziprasidone hydrochloride (ZDH) and its polymeric microspheres-based matrix tablets. The chromatographic separation of ZDH was achieved on a C18 reverse-phase column (250 mm × 4.6 mm, 5µ, Enable) and a C18 guard column using acetonitrile-potassium dihydrogen phosphate buffer (pH 3.6 ± 0.1; 20.0 mM containing 0.2% v/v triethylamine) as a mobile phase in the ratio of 28:72%v/v at a flow rate of 1.0 mL/min which indicated a retention time within a short run time of 2 min. All the analytes were monitored using UV detection. The method was validated according to the International Conference on Harmonization guidelines Q2A and Q2B with respect to specificity, precision, linearity, accuracy, range, stability of analytical solution, robustness and system suitability. The LOQ was 20.0 ng/mL and correlation coefficient (R2) values for the linear range of 20.0-1000.0 ng/mL were 0.990 or greater for all the analytes. The satisfying recoveries (98.68-99.82%) and low relative standard deviation confirmed the suitability of the proposed method for the routine analysis of ZDH in bulk and its formulations. 
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