1Research Scholar, Department of Chemistry, GITAM School of Science, GITAM University, Visakhapatnam - 530045, India
2Technical Assistant in Chemistry, Department of Chemistry, GITAM School of Science, GITAM University, Visakhapatnam - 530045, India
3Faculty in Chemistry, Department of Chemistry, GITAM School of Science, GITAM University, Visakhapatnam - 530045, India
*Corresponding Author: P. V. Subrahmanyam Naidu, Faculty in Chemistry, Department of Chemistry, GITAM School of Science, GITAM University, Visakhapatnam - 530045, India. Email: pparimi@gitam.edu
Received: 16th Dec, 2025; Revised: 8th Feb 2026; Accepted: 12th Feb, 2026; Available Online: 28th Feb, 2026
Rapid LC-MS/MS Method in the Quantitation of N-Nitroso etodolac, A sensitive, reliable LC-MS/MS assay was created in order to identify the cancer causative N-nitroso etodolac contamination in etodolac drug products. Separations were done using a Phenomenex Kinetex(r) C18 150 x 3 mm, 2.6 um UPLC column by using a gradient programmed with Mobile Phase A: 0.1 percent formic acid in water and Mobile Phase B: 0.1 percent formic acid in acetonitrile. Detection was done by the use of triple quadrupole mass spectrometer (in positive electrospray ionization mode) which monitored multiple reaction monitoring (MRM) transitions characteristic of N-nitroso etodolac. This procedure has been shown to be a rapid and inexpensive risk assessment procedure in risk assessment studies of N-nitroso etodolac in etodolac manufacturers in pharma-industry to allow routine analysis and regulatory compliance. It has been demonstrated to comply with ICH Q2(R2) and USP <1225> guidelines, and therefore with: - Linearity: r > 0.99 over the calibrated range - Accuracy (recovery): 93.85% - 108.55%
Keywords: Etodolac, Sciex-5500 LC-MS/MS, N-nitroso etodolac, FDA, and USP
How to cite this article: Ramanjaneyulul M, Ganesh K, Subrahmanyam Naidu PV, The Determination Of N-Nitroso Etodolac (Ndsri) In Etodolac Using A Sensitive Sciex 5500 Lc-Ms/Ms Instrument. Int J Drug Deliv Technol. 2026; 16(2): 489-495; DOI: 10.25258/ijddt.16.2.55
Source of support: Nil.
Conflict of interest: None