Analytical Method Development And Validation For Determination Of Nitrosamine Impurities N-Nitrosodibutylamine (Ndba) & Nitroso Of N-Dimethyl Erythromycin In Sertraline Hcl Drug Substance By Lc-Ms/Ms
Year: 2024
Type: article
Abstract: This work provides a thorough assessment of a method for measuring N-nitrosodibutylamine and N-nitroso of N-dimethyl erythromycin A, two substances with substantial regulatory interest because of their health hazards. The performance characteristics of the method were thoroughly investigated through a series of experiments, including standard solution analysis, quantitation and detection limit determination, linearity assessment, precision testing at various levels, and accuracy evaluation via recovery studies. The findings demonstrate that the technique performs exceptionally well in terms of linearity, accuracy, and precision over a broad range of concentrations. The results indicate that the suggested approach has the potential to accurately quantify these chemicals in a range of sample matrices, making it a useful tool for regulatory compliance and quality assurance in associated industries.
Source: Nanotechnology Perceptions
Authors: Sanjeev Kumar Giri, Upama Misra
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: diamond
OpenAlex ID: W4405085541