Author/Authors :
Abu-Shandi, Khalid Tafila Technical University - Faculty of Science - Department of Chemistry, Jordan , Mohammed, Qasem D Al-Balqa’ Applied University - Faculty of Science - Department of Chemistry, Jordan , Saket, Munib M German Jordanian University - Department of Chemical-Pharmaceutical Eng, Jordan , Qaisi, Ali M University of Jordan - Faculty of Pharmacy - Department of Pharmaceutical Sciences, Jordan , Deabas, Fawaz Al-Balqa’ Applied University - Faculty of Science - Department of Chemistry, Jordan , Massadeh, Adnan M Jordan University of Science and Technology - Department of Medicinal Chemistry and Pharmacognosy, Jordan , Al-Ayed, Omar University of Mutah - Department of Chemical Engineering, Jordan , Al-Momani, Lo’ay TafilaTechnical University - Faculty of Science - Department of Chemistry, Jordan , Abu-Nameh, Eyad S. M Al-Balqa’ Applied University - Faculty of Science - Department of Chemistry, Jordan
Abstract :
This study develops and validates an efficient, sensitive and simple method for the simultaneous determination of cetirizinedihydrochloride and pseudoephedrinecombined 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 wasacetonitrile: 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 μg/mL,respectively,and the limit of detection and quantification for pseudoephedrinewere17.976 and 59.921 μg/mL, respectively. The linearitywas studied in the concentration range of 12.2 and 36.5 μg/mL forcetirizinedihydrochloride and 295.91 and 861.73 μg/mL for pseudoephedrine. The recovered amounts of cetirizinedihydrochloride and pseudoephedrinewere98.2% -102.9% and99.5%- 102.4%, respectively.
Keywords :
cetirizinedihydrochloride , pseudoephedrine , validation , ICH , USP , andHPLC
