A Rapid Stability-Indicating LC Method for Ziprasidone Hydrochloride |
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| Authors: | A Singh B M Rao G R Deshpande S Sangaraju M K Srinivasu M Lalitha Devi P V V Satyanarayana K B Chandrasekhar |
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| Institution: | (1) Analytical Research, Custom Pharmaceutical Services, Dr. Reddy’s Laboratories, Hyderabad, 500 049, India;(2) Quality Control, Unit-I, Bulk Actives, Dr. Reddy’s Laboratories, Medak, India;(3) Department of Chemistry, J.N.T.U. College of Engineering, Anantapur, 515002, India |
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| 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. |
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| Keywords: | Column liquid chromatography Forced degradation RSD and validation Ziprasidone hydrochloride |
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