Abstract

Validated stability-indicating high-performance liquid chromatographicmethod for determination of ziprasidone hydrochloride in bulk drug and dosage form

Author(s): Vitthal D.Dhakane, Sandeep A.Kotharkar, Milind B.Ubale

A stability-indicating high-performance liquid chromatographic assay method was developed and validated for quantitative determination of ziprasidone hydrochloride in bulk drugs and the degradation products generated fromforced decomposition.An isocratic, reversed phase HPLC method was developed to separate the drug from the degradation products, using anYMCPackODS-AC18 (250mm4.6mm, 5) column and the mobile phase containing the mixture of triethylamine-phosphoric acid buffer (pH-3 by orthophosphoric acid), acetonitrile and methanol (53:15:32,v/v/v). The detectionwas carried out atwavelength 230nm. The chromatographic resolution between its degraded products was found to be greeter than three. The ziprasidone hydrochloride was subjected to stress conditions of hydrolysis acid, base, oxidation (30%H2O2), photolysis and thermal degradation. The negligible degradation was observed for ziprasidone hydrochloride in acid and oxidative degradation while in base hydrolysis, and thermal degradation, considerable degradation was observed. The mass balance was close to 100 in all the stress conditions. The degraded products were well resolved from main peak. The developed method was validated with respect to linearity, accuracy recovery, precision, system suitability, selectivity, robustness and forced degradation studies prove the stability indicating ability of the method.