Abstract

METHOD DEVELOPMENT AND VALIDATION REPORT FOR DETERMINATION OF N-NITROSO RANOLAZINE CONTENT IN RANOLAZINE PROLONGED RELEASE (PR) TABLETS 750 MG BY LC-MS/MS

Sanjeev Giri*

ABSTRACT

This work offers a novel method for determining several genotoxic contaminants in ranolazine active pharmaceutical ingredient (API) at the same time with a single LC-MS/MS method. Although the majority of the literature currently in publication concentrates on the identification of specific impurities, our approach provides a thorough solution for concurrent analysis, increasing productivity and efficiency in pharmaceutical manufacturing processes. Critical parameters, such as sensitivity, repeatability, linearity, recovery, and robustness, were determined by thorough experimentation and adherence to ICH standards to evaluate the process's performance. For each of the five contaminants, the calculated Limit of Detection (LOD) and Limit of Quantification (LOQ) values show remarkable sensitivity and accuracy, enabling the detection of minuscule quantities. All things considered, our proven approach shows excellent dependability and This work offers a novel method for determining several genotoxic contaminants in ranolazine active pharmaceutical ingredient (API) at the same time with a single LC-MS/MS method. Although the majority of the literature currently in publication concentrates on the identification of specific impurities, our approach provides a thorough solution for concurrent analysis, increasing productivity and efficiency in pharmaceutical manufacturing processes. Critical parameters, such as sensitivity, repeatability, linearity, recovery, and robustness, were determined by thorough experimentation and adherence to ICH standards to evaluate the process's performance. For each of the five contaminants, the calculated Limit of Detection (LOD) and Limit of Quantification (LOQ) values show remarkable sensitivity and accuracy, enabling the detection of minuscule quantities. All things considered, our proven approach shows excellent dependability and

Keywords: genotoxic impurities, LC-MS/MS, pharmaceutical manufacture, validation of methods, sensitivity, reproducibility, limit of quantification, limit of detection, and safety protocols.