Determination of Related Substance in Levo-cetirizine Hydrochloride Chewable Tablet by RP-HPLC / 中国药房

ABSTRACT

OBJECTIVE:To establish a method for the determination of related substances in Levo-cetirizine hydrochloride chewable tablet. METHODS:RP-HPLC was performed on the column of Venusil XBP-CN with mobile phase of acetonitrile-0.05 mol/L Sodium dihydrogen phosphate solution(pH value adjusted to 3.0 by phosphoric acid)(60∶40,V/V)at a flow rate of 1.0 ml/min, the detection wavelength was 230 nm,column temperature was 25 ℃,and volume injection was 20 μl. RESULTS:Levo-cetirizine hydrochloride chewable tablet showed good separation with related substances;the linear range of levo-cetirizine hydrochloride was 1.2-2.8 μg/ml(r=0.999 9);the quantification limit and detection limit was 1.4 ng/ml and 0.3 ng/ml,respectively;RSDs of preci-sion,stability and reproducibility tests were lower than 1%;recovery was 96.3%-105.0%(RSD=1.7%,n=9);the contents of re-lated substances were no more than 0.17%. CONCLUSIONS:The method is simple,sensitive,reproducible,accurate and reli-able,and can be used for the determination of related substances in Levo-cetirizine hydrochloride chewable tablet.