Degradation of ondansetron: Isolation and characterization impurity D ondansetron as A candidate reference standard impurity in drug

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Abstract

Drug safety does not only depend on the active ingredient of the drug itself but also depends on the contamination contained in it. 1,2,3,9-Tetrahydro-9-methyl-3-methylene-4H-carbazol-4-one, or often called impurity D ondansetron is contamination in ondansetron which can endanger human health if the value is above the minimum (0.1 %) due to its toxicity. The qualitative and quantitative methods of selective and accurate for the impurity D ondansetron need to be developed to ensure the quality of the drug. Qualitative and quantitative analysis of drug contamination is often not possible due to it is constrained by the high-price of standard contaminant. The aim of this study is to obtain impurity D ondansetron that fulfills the requirements for characterization and purity as candidate for standard impurity; and obtain a method of analysis of impurity D ondansetron both qualitatively and quantitatively in ondansetron tablet which is valid in HPLC. The research experiments were carried out by hydrolyzing ondansetron in alkaline condition with optimum concentration 1 M NaOH for 30 h at 80 °C. Impurity D Ondansetron from degradation was successfully isolated by ethyl acetate as a solvent and hexane-ethyl acetate (6:4) as an eluent. The purity of Impurity D Ondansetron was measured using HPLC-DAD and obtained the purity index of 1.0000 and purity of 99.77 %. Impurity D Ondansetron was characterized using infrared spectroscopy, mass spectroscopic gas chromatography and HPLC-DAD.

Original languageEnglish
Title of host publicationProceedings of the 5th International Symposium on Current Progress in Mathematics and Sciences, ISCPMS 2019
EditorsTerry Mart, Djoko Triyono, Tribidasari Anggraningrum Ivandini
PublisherAmerican Institute of Physics Inc.
ISBN (Electronic)9780735420014
DOIs
Publication statusPublished - 1 Jun 2020
Event5th International Symposium on Current Progress in Mathematics and Sciences, ISCPMS 2019 - Depok, Indonesia
Duration: 9 Jul 201910 Jul 2019

Publication series

NameAIP Conference Proceedings
Volume2242
ISSN (Print)0094-243X
ISSN (Electronic)1551-7616

Conference

Conference5th International Symposium on Current Progress in Mathematics and Sciences, ISCPMS 2019
CountryIndonesia
CityDepok
Period9/07/1910/07/19

Keywords

  • characterization
  • degradation
  • impurity D ondansetron
  • isolation
  • ondansetron
  • purity
  • Reference standard

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