BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF LENVATINIB BY RP-HPLC METHODAbstract
A rapid, fast, accurate, and precise method was developed for the estimation of lenvatinib in human plasma using methotrexate as an internal standard by reverse-phase high-performance liquid chromate-graphy (RP-HPLC). The separation was carried out by using zodiasil C18 (150 × 4.6 mm, 5 m) as a stationary phase and 0.01 N sodium di-hydrogen phosphate (pH: 4.8): acetonitrile in the ratio of 45:55 % v/v. The analysis was performed at a flow rate of 1.0 ml/min using PDA detector at 240 nm. The column temperature was maintained at 30 °C for better separation and resolution. The retention time of lenvatinib was found to be 4.508 min. The % coefficient of variation of lenvatinib was found to be 2.66%. The % recovery was found to be 94.758%. The method was found to be linear between the concentration range of 28-1120 ng/mL (r2 = 0.999). The lower limits of quantification were 28 ng/mL, which reach the level drug possibly found in human plasma. Further, the reported method was validated as per the ICH guidelines and found to be well within a suitable range. In the future, this method can be used for clinical and pharmacokinetic studies.
G. K. Veni, A. Ajitha * and K. Abbulu
Department of Pharmaceutical Analysis, CMR College of Pharmacy, Medchal, Kandlakoya, Hyderabad, Telangana, India.
25 July 2019
09 January 2020
09 March 2020
01 July 2020