LIQUID CHROMATOGRAPHY METHOD DEVELOPMENT AND VALIDATION FOR ANALYSIS OF CLONIDINE IN PHARMACEUTICAL DOSAGE
Journal Title: Journal of Atoms and Molecules - Year 2012, Vol 2, Issue 1
Abstract
A new simple, rapid, selective, precise and accurate isocratic reverse phase high performance liquid chromatography assay has been developed and validated for the estimation of CLONIDINE in tablet formulation. The separation was achieved by using C-18 column (250x4.6mm, 5μm in particle size) at ambient temperature coupled with a guard column of silica in mobile phase Methanol : Acetonitrile : water with the pH value adjusted to 5.8 .The flow rate of was 1.5ml/min and the drug was detected using UV detector at the wavelength of 280nm and the run time was 6min. The retention time was within 2.6minutes. The percentage of RSD for precision and accuracy of the method was found to be less than 2%. The method was validated as per ICH guidelines. The proposed method was found to be accurate, repeatability and consistent. It was successfully applied for the analysis of the drug in marketed formulation and could be effectively used for the routine analysis of formulation containing the drug without any alteration in the chromatography conditions.
Authors and Affiliations
Narendra Devanaboyina, B Charan Kumar, B Vijay, M. A Bhanu, V Gayathri
Keywords
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- EP ID EP367400
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