Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE TEST OF DETERMINATION OF NITROSAMINE IMPURITIES N-NITROSODIBUTYLAMINE (NDBA) & NITROSO OF N-DIMETHYL ERYTHROMYCIN A CONTENT IN SERTRALINE HCL DRUG SUBSTANCE BY LC-MS/MS

Sanjeev Giri*

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.

Keywords: Linearity, Precision, Accuracy, Technique validation, Quantification, Limit of detection, The limit of quantitation, N-nitrosodibutylamine, N-nitroso of N-Dimethyl Erythromycin A, and recovery studies.