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.
2. Vengatesh G, Karthik G, Sundaravadivelu M. A comprehensive study of ondansetron hydro-chloride drug as a green corrosion inhibitor for mild steel in 1M HCl medium. Egyptian Journal of Petroleum 2017; 26(3): 705-719.
3. ***European Pharmacopoeia 8th Edition. Ondansetron hydrochloride, 2014.
4. Atrey E, Shende P, Gaud RS. RP-HPLC Method Development and Validation for Simultaneous Estimation of Ondansetron Hydrochloride and Complexed Famotidine in Bulk and Dosage Form. Journal of Analytical and Pharmaceutical Research 2017; 5(2): 00138.
5. Patel S, Patel LG, Thakkar YP et al. Development and Validation of Analytical Method for the Determination of Rabeprazole and Ondansetron in Pharmaceutical Dosage Form by Reversed-phase HPLC. International Journal of ChemTech Research 2010; 2(3): 1531-1536.
6. Zhang H, Ye L, Stewart JT. HPLC Determination of Idarubicin-Etoposide and Idarubicin-Ondansetron Mixtures in 0.9% Sodium Chloride Injection USP. Journal of Liquid Chromatog-raphy & Related Technologies 2006; 21(7): 979-988.
7. Stamate S, Făgărăşan E, Bojiţă M et al. Estimarea cromatografică a ondansetronului şi morfinei din forme farmaceutice. Farmacia, 1998; XLVI(3):11-16.
8. Varvara A, Monciu CM, Arama C et al. Ion Pair Reversed-Phase Performance Liquid Chroma-tography of Ondansetron Hydrochloride using Sodium Heptansulfonate as Counterion. Farma-cia, 2009; 57(4): 442-451.
9. Varvara A, Monciu CM, Arama C et al. The Liquid Chromatographic Assay of Ondansetron Hydrochloride and its Impurities Using a New Stationary Phase. Farmacia 2008; 56(2): 154 -165.
10. Shada R, Darwis Y, Khan N. Development and Validation of an RP-LC-UV Method for the Determination of Ondansetron: Applications to Pharmaceutical Dosage Forms. Chromatographia 2009; 70: 75-81.
Once an article is accepted for publication, MSJ requests a transfer of copyrights for published articles.
The copyright form will be signed by the corresponding author.
COPYRIGHT TRANSFER FORM FOR REVISTA MEDICO-CHIRURGICALĂ A SOCIETĂȚII DE MEDICI ȘI NATURALIȘTI DIN IAȘI
THE MEDICAL-SURGICAL JOURNAL OF THE SOCIETY OF PHYSICIANS AND NATURALISTS FROM IASI
We, the undersigned authors of the manuscript entitled
this manuscript, which is submitted for publication in the REVISTA MEDICO-CHIRURGICALĂ, has not been published and it is not under consideration for publication in another journal.
- we give the consent for publication in the REVISTA MEDICO-CHIRURGICALĂ, in printed and electronic format and we transfer unconditioned and complete the copyright of this manuscript to the REVISTA MEDICO-CHIRURGICALĂ, in the event of its acceptance.
- the manuscript does not break the intellectual property rights of any other person.
- we have read the submitted version of the manuscript and we are fully responsible for the content.
Names and signatures of authors / copyright owners (the following sequence is the authorship of the article):
N.B. All the authors must sign this form