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STABILITY INDICATING UPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF DASATINIB IN PHARMACEUTICAL DOSAGE FORMS
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| Author:
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JAHNAVI BANDLA, S. GANAPATY
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| Abstract:
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The present work describes the stability indicating method development and validation for the determination of
Dasatinib in pharmaceutical dosage form using Ultra Performance Liquid Chromatography with UV detection. The
optimized chromatographic conditions used were Acquity UPLC HSS C18 (100mm × 2.1mm, 1.8µ) column, 0.1%
Orthophosphoric acid and acetonitrile in the ratio (50:50%v/v) as mobile phase run on an isocratic mode at a flow rate
of 0.2ml/min. The column oven temperature was maintained at room temperature. The detection wavelength was found
to be 321nm.The developed method was validatedas per ICH guidelines and found to be specific, rugged and robust. A
linear response was found in the concentration range of 12.5µg/ml to 75µg/ml with correlation coefficient of 0.999,
indicating that the method obeys Beer’s law. The % recovery for Dasatinib was found to be 99.80% to 100.19%
indicating the method was accurate. The % relative standard deviation was found to be 0.7 indicating the method was
precise. The drug was found to be stable at stressed conditions and the net degradation was found to be within the
limits. The developed method can be used for the quality control of Dasatinib in pharmaceutical dosage form
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| Keyword:
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Dasatinib, Stability Indicating, Method development, Validation, UPLC
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| EOI:
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| DOI:
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