Determination of stress-induced degradation products of cetirizine dihydrochloride by a stability-indicating RP-HPLC method

A new, simple and accurate stability-indicating reverse phase high performance liquid chromatography method was developed and validated during the early stage of drug development of an oral lyophilizate dosage form of cetirizine dihydrochloride. For RP-HPLC analysis it was used an Eclipse XDB C8 col...

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Bibliographic Details
Published in:Daru 2014-12, Vol.22 (12), p.1-1
Main Authors: Borges, Paloma Flórez, Lozano, Pilar Pérez, Montoya, Encarna García, Miñarro, Montserrat, Ticó, Josep R, Jo, Enric, Negre, Josep M Suñe
Format: Article
Language:English
Subjects:
Chromatography
Drug dosages
Methods
Particle size
Pharmaceutical industry
Potassium
Studies
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Summary:A new, simple and accurate stability-indicating reverse phase high performance liquid chromatography method was developed and validated during the early stage of drug development of an oral lyophilizate dosage form of cetirizine dihydrochloride. For RP-HPLC analysis it was used an Eclipse XDB C8 column 150 mm x 4.6 mm, 5 μm (Agilent columns, Barcelona, Spain) as the stationary phase with a mobile phase consisted of a mixture of 0.2 M K2HPO4 pH 7.00 and acetonitrile (65:35, v/v) at a flow rate of 1 mL min^sup -1^. Detection was performed at 230 nm using diode array detector. The method was validated in accordance with ICH guidelines with respect to linearity, accuracy, precision, specificity, limit of detection and quantification. The method results in excellent separation between the drug substance and its stress-induced degradation products. The peak purity factor is
ISSN:1560-8115
2008-2231