DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE ESTIMATION OF ZIPRASIDONE IN CAPSULE DOSAGE FORM
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2012, Vol 3, Issue 2
Abstract
A sensitive, reproducible and rapid reverse phase high performance liquid chromatographic methods were developed and validated for the determination of Ziprasidone Hydrochloride Monohydrate (ZHM) in the presence of its degradation products in pure form and in pharmaceutical formulations. Hypersil C8 column (150×4.6mm, 5μ) was used with a mobile phase containing a mixture of 0.02M KH2PO4 (pH‐3), Buffer : Methanol : TEA in the ratio of (70:30:0.1). The flow rate was 1.8ml/min and effluents were monitored at 315nm and eluted at 6.204min. Calibration curve was plotted with a range from 35-65 μg/ml. The assay was validated for the parameters like accuracy, precision, robustness and system suitability parameters. The proposed method can be useful in the routine analysis for the determination of ziprasidone in pharmaceutical dosage forms.
Authors and Affiliations
Bhaskar Banerjee , Pratibha Shrivastava , Shailendra Singh , Tanushree Banerjee
Keywords
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- EP ID EP140302
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