Abstract

STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF DASATINIB AND LENVATINIB BY USING UPLC IN PHARMACEUTICAL DOSAGE FORM

Maheen Sultana* and Dr. Iffath Rizwana

Abstract

Objective: The objective of the method was to develop a new, simple, rapid, efficient, cost effective and reproducible, stability indicating Ultra performance liquid chromatography method for quantification of Dasatinib and Lenvatinib in pharmaceutical dosage form as per ICH guidelines. Methods: Chromatographic analysis was carried out by using UPLC on a water acquity C8 column using a mobile phase sodium phosphate buffer (10mm), pH 3.5 methanol [60:40] was selected as good peak symmetry and resolution between peaks was observed. The flow rate of 0.5ml/min was maintained and detection was carried out at 276nm. The method was validated in terms of linearity, accuracy, precision, LOD, LOQ and robustness as per ICH guidelines. Results: The Retention time of DASATANIB and LENVATINIB were found to be 2.355 and 4.460 min respectively. The From linearity the correlation coefficient R2 value was found to be 0.991 for DASATANIB and 0.990 for LENVATINIB. The proposed UPLC method was also valid Dasatanib for system suitability, system precision and method precision. The % RSD in the peak area of drug was found to be less than 2%. The limit of detection of DASATANIB and LENVATINIB were found to be 0.72µg/ml μg/mL and 3.19 μg/mL and limit of quantitation were 2.20μg/mL for dasatinib and 9.67 µg/ml respectively, The percentage of recovery of DASATANIB and LENVATINIB were found to be 98.74 and 99.42 respectively. The drugs were degraded in thermal, photolytic, acidic, basic and peroxide conditions. The peaks of degraded products were well resolved from the actual drug. The results obtained prove that the developed method is a stability indicating method. Conclusion: The developed RP-HPLC method was simple, rapid, accurate, precise and stability indicating for the dasatinib and lenvatinib in pharmaceutical dosage form.

Keywords: Dasatinib and Lenvatinib; UPLC; Validation; Stability indicating.