Chromatographia

, Volume 65, Issue 3–4, pp 191–196 | Cite as

A Rapid Stability-Indicating LC Method for Ziprasidone Hydrochloride

  • A. Singh
  • B. M. Rao
  • G. R. Deshpande
  • S. Sangaraju
  • M. K. Srinivasu
  • M. Lalitha Devi
  • P. V. V. Satyanarayana
  • K. B. Chandrasekhar
Full Short Communication
First Online:
Received:
Revised:
Accepted:

Abstract

A simple and rapid reversed-phase liquid chromatographic method was developed for the related substances determination and quantitative evaluation of ziprasidone hydrochloride, which is used as an antipsychotic agent. Forced degradation studies were performed on bulk sample of ziprasidone hydrochloride using acid, base, oxidative hydrolysis, thermal stress and photolytic degradation. Mild degradation of the drug substance was observed during thermal stress and considerable degradation observed during base hydrolysis. The chromatographic method was fine tuned using the samples generated from forced degradation studies. Good resolution between the peaks corresponds to synthetic impurities and degradation products from the analyte were achieved on YMC Pack Pro C18 column using the mobile phase consists of a mixture of 0.05% v/v of phosphoric acid in water and acetonitrile. The stressed test solutions were assayed against the qualified working standard of ziprasidone hydrochloride and the mass balance in each case was close to 99.7% indicating that the developed method was stability-indicating. Validation of the developed method was carried out as per ICH requirements.

Keywords

Column liquid chromatography Forced degradation RSD and validation Ziprasidone hydrochloride 
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Notes

Acknowledgments

The authors wish to thank the management of Dr. Reddy’s group for supporting this work. We would also like to thank colleagues in separation science division of Analytical Research of Custom Pharmaceutical Services for their co-operation in carrying out this work.

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Copyright information

© Friedr. Vieweg & Sohn Verlag/GWV Fachverlage GmbH 2006

Authors and Affiliations

  • A. Singh
    • 1
  • B. M. Rao
    • 1
  • G. R. Deshpande
    • 1
  • S. Sangaraju
    • 1
  • M. K. Srinivasu
    • 1
  • M. Lalitha Devi
    • 1
  • P. V. V. Satyanarayana
    • 2
  • K. B. Chandrasekhar
    • 3
  1. 1.Analytical Research, Custom Pharmaceutical ServicesDr. Reddy’s LaboratoriesHyderabadIndia
  2. 2.Quality Control, Unit-I, Bulk ActivesDr. Reddy’s LaboratoriesMedakIndia
  3. 3.Department of ChemistryJ.N.T.U. College of EngineeringAnantapurIndia

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