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