Stability indicating and validation by RP-HPLC for the estimation of Ziprasidone in bulk and its dosage Form

A new simple, sensitive and stability indicating RP-HPLC method for the determination of ziprasidone in pharmaceutical dosage form was developed. Chromatographic separation was carried on RP-C8 column (symmetry 250x4.6mm;5μm) with a mobile phase composed of potassium dihydrogen phosphate buffer (pH 4.5) and acetonitrile (70:30) at an absorption maxima 247nm. Linearity for detector response was observed in the concentration range of 50- 150% of test concentration. Correlation coefficient found to be 1.0. Retention time was found to be 4.1min. Percent recovery studies were found in the range 50-150% of test concentration. Drug product was exposed to acid, base, heat, oxidation and photolytic stress conditions and the samples were analysed by the proposed validated method. Results of the analysis were validated statistically and by recovery studies. The developed method was found to be precise for the determination of ziprasidone in bulk and capsule dosage form.

Author(s): Ramesh babu. A, Vijaya lakshmi. M, Lavanya G

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