Simultaneous Determination of Cetirizine and Pseudoephedrine Combined in Tablet Dosage Form by High Performance Liquid Chromatography

Khalid Abu-Shandi, Qasem D. Mohammed, Munib M. Saket, Ali M. Qaisi, Fawaz Deabas, Adnan M. Massadeh, Omar Al-Ayed, Lo’ay Al-Momani, Eyad S.M. Abu-Nameh

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 linearity was 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.

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