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M. S. Raghu, K. Basavaiah, K. N. Prashanth and K. B. Vinay

Iodometric determination of milligram and microgram amounts of levocetirizine in pharmaceuticals

Abstract

Four simple, selective and sensitive methods are described for the determination of levocetirizine dihydrochloride (LCT) in bulk drug and in tablets. The methods exploit the well-known analytical reaction between iodide and iodate in the presence of acid solution. Iodide present is oxidized by iodate in an amount equivalent to the HCl present in LCT to iodine and the liberated iodine is determined by four different procedures which inturn quantify LCT at varying detection range and sensitiveness. Two direct titrimetric procedures involve titration of iodine by thiosulphate either towards starch end point (method A) or potentiometrically (method B). Both the methods have a reaction stiochiometry of 1:1 (LCT: liberated iodine) and have quantification ranges of 220 mg LCT for method A and method B. The liberated iodine is also measured spectrophotometrically at 350 nm (method C) or the iodine-starch complex measured at 570 nm (method D). In both the methods, the absorbance is found to be linearly dependent on the concentration of iodine which in turn is related to LCT concentration. The calibration curves are linear over 540 and 1.2512.5 g ml1 LCT for method C and method D, respectively. The calculated molar absorptivity and Sandel sensitivity values are 1.0´104 l mol1 cm1 and 0.0435 g cm2, respectively for method C, and their respective values for method D are 2.9´104 l mol1 cm1 and 0.0156 g cm2. The intra-day and inter-day accuracy and precision studies were carried according to the ICH guidelines. The method was successfully applied to the analysis of two brands of tablets LCT. The accuracy was also checked by placebo blank and synthetic mixture analyses besides recovery study via standard addition procedure.
Key words: spectrophotometry, levocetirizine, titrimetry, Potentiometry, pharmaceuticals.
Moscow University Chemistry Bulletin.
2012, Vol. 53, No. 6, P. 417
   

Copyright (C) Chemistry Dept., Moscow State University, 2002
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