Ultraviolet spectrophotometric validation of dissolution method for Levocetirizine dihydrochloride tablets

Abstract

The objective of the present work was to develop and validate a dissolution method for Levocetirizine dihydrochloride LCTZ tablet using ultraviolet spectrophotometry. The dissolution steps were based on the use of the paddle apparatus. The analytical assay was based on absorbance measurements at maximum absorption 236.5nm. Beer Lambert’s law was obeyed in the concentration range 2 - 22 mg. The correlation coefficient was 0.9998 with a relative standard deviation of 0.62%. Results of analysis were validated statistically and by recovery studies. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision, and robustness, stability, limit of detection and limit of quantitation. The proposed method can be successfully applied in routine work for the determination of LCTZ in tablets.