Two simple, economical, precise and accurate methods are described for the simultaneous determination of Lafutidine (LAFU) and Domperidone (DOM) in combined tablet dosage form. The first method (Method A) is Absorption Corrected Method and second method (Method B) is First Order Derivative Spectrophotometry.The amplitudes at 258.0 nm and 299.85 nm in the Absorption Corrected Method and 301.87 nm and 276.18 nm in the first order derivative Spectrophotometry were selected to determine Lafutidine (LAFU) and Domperidone (DOM), respectively in combined formulation. Beer’s law is obeyed in the concentration range of 2-10μg/ml for Lafutidine (LAFU) and 6-30 μg/ml for Domperidone (DOM) for both methods. The methods were validated by following the analytical performance parameters suggested by the International Conference on Harmonization (ICH). All validation parameters were within the acceptable range. The % assay in commercial formulation was found to be in the range 99.12-100.2 % for Lafutidine (LAFU) and 98.52-99.25 % for Domperidone (DOM) by the proposed methods. The methods were validated with respect to linearity, precision and accuracy. Recovery was found in the range of 98.12-100.24% for Lafutidine (LAFU) and 99.53-100.34% for Domperidone (DOM) by absorbance corrected method and 98.32-99.24% for Lafutidine (LAFU) and 99.10-100.02% for Domperidone (DOM) by First Order Derivative. The methods developed are simple, economical, precise and accurate and can be used for routine quality control of analytes in combined tablets.
Select your language of interest to view the total content in your interested language