RP-HPLC Method for Development and Validation of Dasatinib in Bulk, Tablets Applied in Nano suspension, Drug Entrapment Efficiency and Serum

A simple, precise, accurate and robust RP-HPLC method was developed and validated for the determination of dasatinib in bulk and its Tablets, Nano-suspension drug entrapment efficiency and serum. The software used is EZ Chrome and the column employed is Syncronis C18 (250 mm × 4.6 mm, 5 μm particle size). Acetonitrile: Methanol: water 45:35:20 (v/v) was used as mobile phase at a flow rate of 1 mL min with UV detection at 325 nm. Linearity was observed in the concentration range of 1–6 μg mL with regression equation y =40966x-6534(R = 0.999). The Nanosuspension prepared by novel precipitation-combined ultra-sonic homogenization technique and was then characterized by using particle size analysis, zeta potential measurement. Liquidliquid extraction is performed for isolation of the drug and elimination of serum interferences samples of serum was extracted with 50μL of ortho phosphoric acid and 3ml of methanol was added and spiked with dasatinib. The method was validated as per ICH guidelines. The RSD for intra-day (99.2) and inter-day (98.3) precision were found to be less than 2 %.The developed method is simple, precise and robust for the determination of dasatinib in bulk and applied to tablets, Nano-suspension, drug entrapment efficiency and serum.