Abstract
A simple, sensitive, and reproducible ultra-performance liquid chromatography (UPLC) coupled with a photodiode array detector method was developed for the quantitative determination of Ziprasidone Hydrochloride (ZIP) in API and pharmaceutical dosage forms. Chromatographic separation was achieved on an Acquity UPLC BEH 100-mm, 2.1-mm, and 1.7-µm Shield RP-18 columns, and within a short runtime, that is, within 8.0 min. The eluted compounds were monitored at 230 nm, the flow rate was 0.3 mL/min, and the column oven temperature was maintained at 27°C. The resolution of ZIP and seven (potential, bi-products, and degradation) impurities were greater than 2.0 for all pairs of components. The high correlation coefficient (r2 > 0.9992) values indicated clear correlations between the investigated compound concentrations and their peak areas within the test ranges. The repeatability and intermediate precision, expressed by the RSD, were less than 2.0%. The accuracy and validity of the method were further ascertained by performing recovery studies via a spike method. The accuracy of the method expressed as relative error was satisfactory. The drug was subjected to the International Conference on Harmonization (ICH)-prescribed hydrolytic, oxidative, photolytic, and thermal stress conditions. The performance of the method was validated according to the present ICH guidelines.
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