DEVELOPMENT OF A NEW RP-HPLC METHOD FOR ONDANSETRON DETERMINATION IN INJECTABLE FORMULATIONS

  • Alina BALINT University of Medicine and Pharmacy from Tîrgu Mureş, Romania
  • Silvia IMRE University of Medicine and Pharmacy from Tîrgu Mureş, Romania
  • Zelma BONDOROI-PAPP University of Medicine and Pharmacy from Tîrgu Mureş, Romania
  • Daniela-Lucia MUNTEAN University of Medicine and Pharmacy from Tîrgu Mureş, Romania

Abstract

The aim of this study was to develop a simple, rapid and efficient reversed phase HPLC-UV method for ondansetron assay in injectable dosage forms. Material and methods: Analyses were performed with the aid of an 1100 series HPLC system (Agilent Technologies USA) by using an Inertsil ODS 150x4.6 mm column with 3 μm particle size (GL Sciences, Japan), operated at 45oC temperature. The mobile phase consisted of 70% KH2PO4 20 mM with triethylammonium phosphate and 30% acetonitrile and it was delivered at a flow rate of 1.5 mL/min. The detection was done at 216 nm. Results: Different chromatographic conditions were tested to reduce the time of analysis and to improve the chromatographic efficiency, with symmetry factor between 0.8-1.2. After establishing the optimal analytical conditions, analytical performance studies have been carried out. Linearity study reveals a good correlation in the concentration range 30 µg/mL – 70 µg/mL. Method accuracy and precision were less than 2%. Under the HPLC-UV specified conditions, ondansetron hydrochloride was separated with a retention time less than 2 minutes, with peak symmetry of 0.87 and adequate results at the validation tests. Conclusions: The proposed method allows a rapid analysis of ondansetron from injections by using a simple reversed stationary phase.

Author Biographies

Alina BALINT, University of Medicine and Pharmacy from Tîrgu Mureş, Romania

Faculty of Pharmacy
Department of Analytical Chemistry and Drug Analysis

Silvia IMRE, University of Medicine and Pharmacy from Tîrgu Mureş, Romania

Faculty of Pharmacy
Department of Analytical Chemistry and Drug Analysis

Zelma BONDOROI-PAPP, University of Medicine and Pharmacy from Tîrgu Mureş, Romania

Faculty of Pharmacy
Department of Analytical Chemistry and Drug Analysis
Farmacia Corola, Tîrgu Mureş, Romania

Daniela-Lucia MUNTEAN, University of Medicine and Pharmacy from Tîrgu Mureş, Romania

Faculty of Pharmacy
Department of Analytical Chemistry and Drug Analysis

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Published
2018-04-04