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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.
ACKNOWLEDGMENTS
The authors wish to thank the management of Dr. Reddy's group, M. V. N. Brahmeshwara Rao and T. Poornachander for supporting this work.
Notes
Linearity range is LOQ 150% with respect to 0.05 mg/mL of Ziprasidone for Impurities.
Linearity range is 50–150% with respect to 0.005 mg/mL of Ziprasidone for assay.
# six determinations using LOQ solution for impurities and 0.005 mg/mL for assay of Ziprasidone.