Volume - 13 | Issue-1
Volume - 13 | Issue-1
Volume - 13 | Issue-1
Volume - 13 | Issue-1
Volume - 13 | Issue-1
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.