Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING METHOD FOR ASSAY DETERMINATION OF ZIPRASIDONE HCL BY USING RP-UPLC ANALYTICAL METHOD

T. Siva Rao*, Tene Sivaganesh, K. Ramasrinivas, U. Sesham Raju and Arun Mendiratta

Abstract

Method development, validation and stability indicating RP-UPLC method for Assay determination of Ziprasidone Hcl in pharmaceutical products. This method has high degree of performance to separation and quantification of Ziprasidone even in the presence of its impurities. This efficient Separation can be achieved by using new Waters Acquity CSH Phenyl hexyl with dimensions (100mm x 2.1 mm, 1.7μm). The buffer used in this method KH2PO4 at pH 2.5 and Acetonitrile in the ratio of (70:30 v/v) with a flow rate of 0.3 ml/min and the absorbance was monitored at 209 nm. The total run time was 3.0 min. The correlation coefficient of the method shows good linear relationship with 0.9999. The limit of detection and quantification are determined for Ziprasidone HCl 0.01μg/ml and 0.03μg/ml. The signal to noise ratio has been observed 4 and 15 for LOD & LOQ respectively. The precision of the method is less than 0.60% and the % recovery of Ziprasidone HCl is between 99.8 – 100.9%. When the drug is subjected to different stress conditions and the resulting degradation products obtained were not interfere during the determination of Ziprasidone HCl.

Keywords: Ziprasidone HCl, RP-UPLC, Method development, Validation, Stabilityindicating.