摘要
This study develops and validates an efficient, sensitive and simple method for the simultaneous determination of cetirizine dihydrochloride and pseudoephedrine combined in tablet dosage form by high performance liquid chromatography [HPLC] with an ultraviolet [UV] detector.The validation of this method was carried out according to ICH and USP guidelines. In this study, the mobile phase used was acetonitrile: water [530:470 [v/v]] with 200mg sodium heptane sulfonic acid and the pH value was adjusted to 2.5 with sulfuric acid. The limit of detection and quantification for cetirizinedihydrochloride were 0.805 and 2.685 microg/mL, respectively, and the limit of detection and quantification for pseudoephedrine were 17.976 and 59.921 microg/mL, respectively. The linearity was studied in the concentration range of 12.2 and 36.5 microg/mL forcetirizinedihydrochloride and 295.91 and 861.73 microg/mL for pseudoephedrine. The recovered amounts of cetirizinedihydrochloride and pseudoephedrine were 98.2% -102.9% and 99.5%- 102.4%, respectively.