Sat, 18 Nov 2017

Development and Validation of Reverse Phase High Performance Liquid Chromatographic Method for Estimation of Ketoconazole in Tablet Dosage Form

Paresh U. Patel 1, Zalak K. Patel1*

1.Department of Quality Assurance, S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Ganpat Vidyanagar, Mehsana, Gujarat, India.


ABSTRACT

This research manuscript describes simple, sensitive, accurate, precise and repeatable reverse phase high performance liquid chromatography method for the estimation of Ketoconazole in tablet dosage form. The sample was analyzed by reverse phase ACE 5 C18 column (150 mm × 4.6 mm i.d, 5 μm particle size) as stationary phase; methanol: acidic water  [91:9, v/v] pH 3.0 as a mobile phase at a flow rate of 0.85 ml/min. Quantification was achieved with Photo Diode Array detector at 243 nm. The retention time for Ketoconazole was found to be 2.764 min. The linearity was obtained in the concentration range of 5-40 µg/ml for Ketoconazole. The method was successfully applied to tablet because no chromatographic interferences from formulation excipients were found. The method retained its accuracy and precision when the standard addition technique was applied.

Keywords: Ketoconazole, RP-HPLC, Method validation.

 


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