RP-UPLC METHOD DEVELOPMENT AND VALIDATION FOR QUANTITATIVE ESTIMATION OF LEVOCETIRIZINE IN LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS

Current analytical research and experiments provide the development of a simple, sensitive, accurate, rapid, and stability indicative RP-UPLC method for estimation of Levocetirizine in Levocetirizine dihydrochloride tablets. This development was achieved using a Waters Acquity UPLC with BEH, C18 column of dimensions of 100 mm × 2.1 mm, 1.7 µm column at 0.3 mL/min flow rate and Acquity TUV detector at 230 nm. This method was validated based on the guidelines of the International Council on Harmonization (ICH). Linearity was demonstrated at 25% to 150% levels with R² value of 0.999. Precision and accuracy were in line with the ICH guidance with a mean recovery of 99.02%. The RP-UPLC method is sensitive with levels of Limit of detection (LOD) and Limit of Quantitation (LOQ) at 0.04µg/mL and 0.12µg/mL, respectively. Degradation studies in conditions of Oxidation, Acid, Base, Temperature, Water, UV light demonstrate there is no placebo as well as degradation impurities interfering with the Levocetirizine main peak. The simple, sensitive, accurate, rapid, and stability-indicating method makes it an efficient tool in routine quality control testing of the active pharmaceutical ingredient as well as in formulations.