This paper is published in Volume-4, Issue-2, 2018
Area
Pharmacutical Chemistry
Author
Hemant Madhusudan Gandhi , Nageswara Rao Gollapalli, Dr. Jaydeep Kumar D. Lilakar
Org/Univ
Dr. Reddy’s Laboratories, Hyderabad, Telangana, India
Keywords
Ondansetron, Impurities, Drug-excipient interaction, Characterization, Excipient impurities.
Citations
IEEE
Hemant Madhusudan Gandhi , Nageswara Rao Gollapalli, Dr. Jaydeep Kumar D. Lilakar. Identification, isolation and characterization of unknown impurity in Ondansetron Drug product, International Journal of Advance Research, Ideas and Innovations in Technology, www.IJARIIT.com.
APA
Hemant Madhusudan Gandhi , Nageswara Rao Gollapalli, Dr. Jaydeep Kumar D. Lilakar (2018). Identification, isolation and characterization of unknown impurity in Ondansetron Drug product. International Journal of Advance Research, Ideas and Innovations in Technology, 4(2) www.IJARIIT.com.
MLA
Hemant Madhusudan Gandhi , Nageswara Rao Gollapalli, Dr. Jaydeep Kumar D. Lilakar. "Identification, isolation and characterization of unknown impurity in Ondansetron Drug product." International Journal of Advance Research, Ideas and Innovations in Technology 4.2 (2018). www.IJARIIT.com.
Hemant Madhusudan Gandhi , Nageswara Rao Gollapalli, Dr. Jaydeep Kumar D. Lilakar. Identification, isolation and characterization of unknown impurity in Ondansetron Drug product, International Journal of Advance Research, Ideas and Innovations in Technology, www.IJARIIT.com.
APA
Hemant Madhusudan Gandhi , Nageswara Rao Gollapalli, Dr. Jaydeep Kumar D. Lilakar (2018). Identification, isolation and characterization of unknown impurity in Ondansetron Drug product. International Journal of Advance Research, Ideas and Innovations in Technology, 4(2) www.IJARIIT.com.
MLA
Hemant Madhusudan Gandhi , Nageswara Rao Gollapalli, Dr. Jaydeep Kumar D. Lilakar. "Identification, isolation and characterization of unknown impurity in Ondansetron Drug product." International Journal of Advance Research, Ideas and Innovations in Technology 4.2 (2018). www.IJARIIT.com.
Abstract
A new degradant of ondansetron was detected at a level of 0.5 % w/w during the reversed phase HPLC analysis in ondansetron 4mg and 8mg stability storage samples. This impurity was identified by LC-MS and was characterized by NMR (1H NMR, 13C NMR, and 2D NMR), LC/MS/MS and FTIR spectral studies. This impurity was prepared by isolation from the impurity enriched samples of ondansetron monohydrochloride dihydrate by using reversed phase preparative HPLC. Based on the spectral data, this impurity was named as carboxy (2-methyl-1-((9-methyl-4-oxo-2,3,4,9-tetrahydro-1H-carbazol- 3-yl)methyl)-1H-imidazol-3-ium-3-yl)methanide chloride. The identification, formation and structure elucidation of this impurity has been discussed in details.
