Article · Volume 51, Issue 4S · pp. s769–s775
Stability Indicating HPLC Method Using Core Shell Stationary Phase for the Determination of Related Substances in Levocetirizine Dihydrochloride Oral Solution
Venkata Krishna Akula1,2,3, Barij Nayan Sinha1, Han Jeong seok2
- 1Birla Institute of Technology, Mesra, Ranchi-835215, INDIA.
- 2CJ Pharma Research India Pvt. Ltd, Hyderabad- 500072, INDIA.
- 3Hetero Labs Ltd., Hyderabad-500055, INDIA.
Abstract
Rationale: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. Experimental: Eight potential related impurities of LCZ were separated and identified in the bulk drug as well as oral solution dosage form. 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.Results: The results were monitored and analytes were quantified at 230 nm. The method 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.
Keywords: HPLC; Core shell; Related Substances; Levocetirizine dihydrochloride
The full text of this article is available as a PDF. Open the PDF.