Validated Reversed Phase High-Performance Liquid Chromatographic Technique for Determination of Dasatanib in Dosage Form: Applications to Stability Studies (Research Article)

Author(s): Smruti Ranjan Mohanthy* and Susanta Kumar Panda

Abstract: An accurate reverse phase High Performance liquid chromatography (RP-HPLC) method has been developed, validated and applied to Stability indicating studies to determine Dasatinib in dosage form. Optimized chromatographic conditions were achieved by using Symmetry, C18, 250mm x 4.6mm.i.d., 5m Particle sizeas stationary phase and Phosphate Buffer: Acetonitrile = 45:55 (pH-6.2) as eluent at flow rate 1.0 ml/min. UV detection was performed at 305nm. The retention time was found at 4.392 min. The method shows linearity over a range of 25 μg/ml to 150 μg/ml. The correlation coefficient 0.998. The results of system suitability test, linearity, precision, accuracy, robustness, specificity, LOD, LOQ and stabilities found are within the acceptance range. The developed method has been validated statistically as per ICH guidelines. A specific, sensitive, economic stability indicating RP-HPLC method for estimation of Dasatinib has been developed based on ICH Guidelines with bulk and dosage forms. Hence it can be applied for routine analysis of Dasatinib in bulk drug and the Pharmaceutical formulations.

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