Vol. 4, Issue 12 (2017)
Ultraviolet spectrophotometric validation of dissolution method for Levocetirizine dihydrochloride tablets
Author(s): Alyah AA Almamoun, Mohamed Elmukhtar Abdel Aziz
Abstract: Among other antihistamines, Levocetirizine dihydrochloride (LCTZ) is designed to have increased efficacy with less harmful drug reaction. And among other spectrophotometry quantitation methods, ultraviolet spectrophotometry is increasingly becoming the technique of choice for assay and dissolution studies of pharmaceutical formulations. The objective of the present work was to develop and validate a dissolution method for LCTZ tablet using ultra violet spectrophotometry. The dissolution steps were based on the use of the paddle apparatus. The analytical assay was based on absorbance measurements at absorption maximum at 236.5nm Beer's law was obeyed in the concentration range from 2 to 22 mg. The correlation coefficient was 0.9998 with a relative standard deviation (RSD %) of 0.62%. Results of analysis were evaluated statistically and by recovery studies. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision, and robustness. The proposed methods can be successfully applied in routine work for the determination of LCTZ in tablet dosage form.