DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF LEVOCETIRIZINE DIHYDROCHLORIDE

Levocetirizine Dihydrochloride is an orally active, non-sedative antihistamine drug. To determine the assay content of Levocetirizine Dihydrochloride drug substance, a very simple, accurate, specific, and precise UV-Spectrophotometric method has been built up as well as evaluated. The suggested method comprises dissolving Levocetirizine Dihydrochloride in distilled water and subjecting the consequential solution to UV Spectroscopic measurement. An absorption maximum was found to lie at about 230 nm and the measurements were carried out at this wavelength. Beer’s law was followed in the concentration range of 4 to 32 μg/ml. The linearity showed on the calibration curve between concentration and absorbance by the line equation of y = 0.0304x + 0.0002 (R² = 0.9997). Reproducibility by repeating methods as %RSD was found to be less than 2%. The results of the accuracy and precision were found very satisfactory and here the suggested method was statistically validated as per the ICH guidelines in terms of specificity, linearity, accuracy, precision and robustness. Validation studies have discovered that the method is simple, specific, rapid, reproducible, precise, accurate and economical which is useful for the routine analysis of Levocetirizine Dihydrochloride.