Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION: PRACTICAL ASPECTS OF INCREASING ANALYSIS SPEED BY MINIMIZING RUN TIME AND RETENTION TIME USING LEVOCETIRIZINE AND ITS APPLICATION TO COMMERCIAL PRODUCT

Priyanka Pataskar*, Dr. Gayatri Barabde, Dr. Sushama Ambadekar and Jayesh Tamhanekar

Abstract

Background: A simple, specific, linear, precise and accurate reverse phase liquid chromatographic method was developed to analysis speed by minimizing run time and retention time of Levocetirizine in tablet dosage forms. The chromatographic separation was performed using Atlantis R dC 18 Column (4.6 mm X 100 mm, 3 μm particle size). Mobile phase composed of methanol and water (70:30 v/v) was selected and a flow rate of 1.000 ml/minute is monitored with injection volume of 5 μl. Detection was carried out at 230 nm. The method was validated as per ICH guidelines. The retention time for Levocetirizine is observed as 1.34 minutes. Linearity range was observed in concentration of 50 - 150 μg/ml for Levocetirizine. The percentage recovery of Levocetirizine is 100%. The correlation coefficients for both the components are close to 1. The proposed method was validated and successfully applied to the estimation of Levocetirizine in tablet dosage forms.

Keywords: Levocetirizine, method development, Validation.