Novel RP-HPLC Method Development and Validation of Dasatinib and Lenvatinib in Bulk and Pharmaceutical Dosage Forms

Dr. K. Nageswara Rao^1*, ²Raghava Doonaboyina, Hope Evangeline^3
1Professor and Head, Department of Pharmaceutical Analysis, K.G.R.L College of Pharmacy, KGRL Road, Bhimavaram, West Godavari, Andhra Pradesh, India.
²Associate Professor and Head, Department of Pharmaceutical Chemistry, K.G.R.L College of Pharmacy, KGRL Road, Bhimavaram, West Godavari, Andhra Pradesh, India.
³K.G.R.L College of Pharmacy, KGRL Road, Bhimavaram, West Godavari, Andhra Pradesh, India.

A B S T R A C T
A new method was established for simultaneous estimation of Dasatinib and Lenvatinib by RP-HPLC method. The chromatographic conditions were success fully developed for the separation of Dasatinib and Lenvatinib by using ThermosilC18 column (4.0×125mm)5µ, flow rate was 1ml/min, mobile phase ratio was (70:30 v/v) methanol: Sodium acetate buffer pH 3 (pH was adjusted with orthophosphoricacid), detection wavelength was 252nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2690, photo diode array detector 996, Empower-software version-2. The retention times were found to be 2.566 mins and 3.417 mins. The % purity of Dasatinib and Lenvatinib was found to be 101.27% and 99.97% respectively. The system suitability parameters for Dasatinib and Lenvatinib such as theoretical plates and tailing factor were found to be 4668, 1.3 and 6089 and 1.2, the resolution was found to be 6.0. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study Dasatinib and Lenvatinib was found in concentration range of 5µg-25µg and 50µg-250µg and correlation coefficient (r²) was found to be 0.999 and 0.999, % recovery was found to be 99.56% and 99.48%, %RSD for repeatability was 0.86 and 0.82, % RSD for intermediate precision was 0.44 and 0.19 respectively. The precision study was precise, robust, and repeatable.LOD value was 3.17 and 5.68, and LOQ value was 0.0172 and 0.2125 respectively. Hence the suggested RP-HPLC.
Keywords: Thermosil C18 column, Dasatinib and Lenvatinib, RP-HPLC