.

ISSN 2063-5346
For urgent queries please contact : +918130348310

METHOD DEVELOPMENT FOR DETERMINATION OF %DRUG RELEASE IN DISSOLUTION FOR AFATINIB TABLETS 20 mg AND 50 mg BY RP-HPLC WITH PDA DETECTOR

Main Article Content

Deepti Kolli 1*, Yaramala Ravindrasena Reddy 1, Madhusudhana Reddy Nimmakayala 1, Konatham Teja Kumar Reddy
» doi: 10.31838/ecb/2023.12.3.112

Abstract

Background: This paper summarizes the method development for determination of %drug release of dissolution for afatinib tablets 20 mg and 50 mg by HPLC. Methods: Afatinib tablets were tested using a Zorbax SB C18 (150 mm X 4.6 mm), 5 μm stationary phase. At a flow rate of 1ml/min, the mobile phase was composed of acetonitrile and buffer solution in a 60:40 (percent v/v) ratio. The elution was measured with a PDA detector at 260nm detection wavelength. International Council for Harmonization (ICH) guidelines were used to validate the proposed approach. Results: The chromatographic peaks of afatinib in this investigation showed good resolution with a retention duration of 3.9 min. Afatinib had excellent linearity, with a correlation value of 0.9997. Other validation factors, such as precision, specificity, accuracy, and robustness, indicated good dependability in Afatinib quantification.

Article Details