Abstract

NEW STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT FOR ANALYSIS OF ZIPRASIDONE IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORM

Dr. Deepak Basedia*1, Dr. B. K. Dubey1, Prabhat Kumar Jain2, Suresh Dhakar, Amit Kumar Jain1, Zeeshan Ali1

1. Technocrats Institute of Technology- Pharmacy Education & Research, Bhopal (M.P.)

2. Scan Research Laboratories, Bhopal (M.P.)

ABSTRACT

A simple, inexpensive, rapid and novel stability indicating isocratic HPLC method has been developed and validated for quantitative analysis of ziprasidone in the bulk drug and in a pharmaceutical dosage form. An isocratic separation of ziprasidone was achieved on Thermo C₁₈ column (4.6 x 250mm, 5μ particle size) as the stationary phase with a flow rate of 1.0 ml/min and using a UV detector to monitor the eluate at 254 nm. The mobile phase consisted of Methanol: Acetonitrile (60:40v/v) enabled separation of the drug from its degradation products. The method was validated for linearity, accuracy (recovery), precision and specificity. The linearity of the method was satisfactory over the range 5-25µg/ml (correlation coefficient 0.999). Recovery of ziprasidone from the pharmaceutical dosage form ranged from 99.69 to 99.78%. ziprasidone was subjected to stress conditions (hydrolysis (acid, base), oxidation, photolysis and thermal degradation) and the samples were analyzed by this method. The forced-degradation study with ziprasidone was shown that it was degraded under acidic condition. The drug was stable under the other stress conditions investigated. The degradation products were well resolved from main peak. The forced degradation study prove the stability indicating power of the method and therefore, the validated method may be useful for routine analysis of ziprasidone as bulk drug, in respective dosage forms, for dissolution studies and as stability indicating assay method in pharmaceutical laboratories and industries.

Keywords: RP-HPLC, ziprasidone, Forced degradation, Method validated.