Stability Indicating HPLC Method using Core Shell Stationary Phase for the Determination of Related Substances in Levocetirizine Dihydrochloride Oral Solution

Introduction: Levocetirizine (LCZ) is a new generation antihistamine drug used for the allergic symptoms resulting from various diseases. The present research work focuses on the development of a simple and precise HPLC method for the effective separation and quantitative determination of LCZ and its impurities. Objectives: Eight potential related impurities of LCZ were separated and identified in the bulk drug as well as oral solution dosage form. Results: The separation was achieved on a core shell stationary phase Kinetex bipheyl (250, 4.6×5 μm) column with mobile phase of sodium perchlorate in water and acetonitrile in a gradient elution. The results were monitored and analytes were quantified at 230 nm. Conclusion: The proposed method was stability indicating and was validated as per ICH guidelines for specificity, linearity, precision, accuracy and robustness. The proposed method finds its application in the routine analysis of LCZ in bulk drug and various dosage forms.