TITLE:
A Useful UFLC-MS Technique for Analysing N-Nitroso Vortioxetine Is a Nitrosamine Drug Substance Related Impurities (NDSRIs) in Vortioxetine Hydrobromide Drug Substance Employing a Low-Cost Single Quadrupole Mass Spectrometer
AUTHORS:
Hanif Shaikh, Akash Gursal, Prashant Patil, Dilip Birati, Pradip Tarde, Sanjay A. Jadhav, Parag Chavan
KEYWORDS:
Ultra-Fast Liquid Chromatography with Mass Spectrometer (UFLC-MS), Nitrosamine Drug Substance Related Impurities (NDSRIs), N-Nitroso Vortioxetine, Vortioxetine Hydrobromide
JOURNAL NAME:
American Journal of Analytical Chemistry,
Vol.16 No.11,
November
26,
2025
ABSTRACT: Nitrosamine Drug Substance Related Impurities (NDSRIs) are commonly examined using High Performance Liquid Chromatography (HPLC) in combination with Mass Spectrometry (MS) detection. Due to the great sensitivity needed, high-resolution MS or MS/MS is commonly used. However, it can be difficult to use this kind of strategy for routine analysis at a supply site. Here, we used a low-cost single quadrupole MS instrument to develop and validate a practical, reliable, and user-friendly method for analysing NDSRIs. As an antidepressant drug used to treat Major Depressive Disorder (MDD) in adults, we have utilized 1-{2-[(2,4-dimethylphenyl) thio] phenyl}-4-nitrosopiperazine (N-Nitroso Vortioxetine) in Vortioxetine Hydrobromide API. The limits of detection and quantification for N-Nitroso Vortioxetine, which may be present in Vortioxetine Hydrobromide API, were 0.660 ppm and 1.995 ppm, respectively. We designed and validated this in accordance with the criteria of the International Harmonization Conference (ICH Q2R2). With a percentage RSD of 1.07 percent, the precision for N-Nitroso Vortioxetine is established. The correctness of the procedure was ensured by the linearity study’s correlation coefficient of 0.99964 and the percentage recovery of the spiked impurity in the drug material obtained, which fell within LOQ and 150% for a 1.995 ppm to 30 ppm level. The N-Nitroso Vortioxetine impurity in Vortioxetine Hydrobromide API can be found by adapting the method.