Abstract

DEVELOPMENT AND VALIDATION OF HPLC ASSAY METHOD FOR THE QUANTITATIVE DETERMINATION OF CETRIZINE IN BULK DRUGS

G. Amarnatha Reddy* and K. Hussain Reddy

ABSTRACT

The drug substance was subjected to stress conditions of hydrolysis, oxidation, UV and thermal degradation. The degradation of Cetrizine was observed under oxidative hydrolysis. The drug was found to be stable to other stress conditions attempted. Successful separation of the drug from the synthetic degradation product formed under stress conditions was achieved on a Zodiac C18, 250×4.6mm ID, 5μm particle size using a mixture of phosphate buffer: methanol (40:60) as mobile phase. The flow rate was 1.0ml/min and the detector was set at 254 nm. The developed HPLC method was validated with respect to linearity, accuracy, specificity and robustness. The retention times of Cetrizine 2.4 minutes and its main oxidative hydrolysis degradation product were found to be 5.389 min and 2.729 min, respectively. Linearity was established for Cetrizine in the range of 0.5–50 mg/ml. The percentage recovery of Cetrizine was found to be 99.91±0.74. Because this method effectively separates Cetrizine from its oxidative degradation products. The developed HPLC method for assay determination of Cetrizine can be used to evaluate the quality of regular production samples. It can be also used to test the stability samples of Cetrizine. The developed HPLC method was accurate and precise for all the API and dosage forms studied with a recovery of 98 to 102%.

Keywords: Reverse Phase Liquid Chromatography, Cetrizine, Degradation products.