Mon, 20 Nov 2017

Development and Validation of RP-HPLC Method for Estimation of Dasatinib in bulk and its Pharmaceutical formulation

 

Arun Kumar Kalekar1*, B Ananta Rao1, Yaswanth Allamneni1, P Dayananda Chary1, S Shanth Kumar1, Navya Allamneni2

1. Research and Development Department, Natco Pharma Limited, Kothur, Mahaboobnagar, Andhra Pradesh – 509228.

2. Department of Pharmaceutical Technology, Narasaraopeta Institute of Pharmaceutical Sciences, Narasaraopeta, Guntur, Andhra Pradesh, India.


 

ABSTRACT

 

An isocratic reverse phase liquid chromatography (RP-HPLC) method has been developed and subsequently validated for the determination of Dasatinib in Bulk and its pharmaceutical formulation. Separation was achieved with a Cosmicsil BDS C18 ((Make: Nomura chemicals (Japan); 150 x 4.6mm I.D; particle size 5 μm)) Column and Triethlyamine buffer (pH adjusted to 6.5 ± 0.05 with diluted orthophosphoric acid): Maethanol and Acetonitrile (50:50) v/v as eluent at flow rate 1.0 mL/min and the Column temperature was 35°C. UV detection was performed at 315 nm and sample temperature was maintained at 5°C. The method is simple, rapid, and selective. The described method of Dasatinib is linear over a range of 3.821 μg/mL to 57.314 μg/mL. The method precision for the determination of assay was below 2.0% RSD. The percentage recoveries of active pharmaceutical ingredient (API) from dosage forms ranged from 98.5 to 99.8 %. The method enables accurate, precise, and rapid analysis of Dasatinib. It can be conveniently adopted for routine quality control analysis of Bulk and pharmaceutical formulations.

Keywords: RP-HPLC, Dasatinib, tyrosine kinases


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