Development and Validation of RP-HPLC Method for the Detection of N-Nitroso Meglumine in Pharmaceutical Products

Abstract

Meglumine, a versatile pharmaceutical excipient utilised in the manufacture of numerous pharmaceutical formulations, is an amino sugar containing a secondary amine, which can form a N-nitroso meglumine under nitrosating conditions. These substances are known to be human carcinogens and mutagens. Thus, the development of trustworthy analytical methods has become increasingly essential. This study offers a structural evaluation and development of a reverse phase chromatographic method for the identification and quantification of impurity. The separation was achieved by utilising a Primesep 100, chromatographic column having a mobile phase consisting of water, acetonitrile and formic acid. An HPLC system equipped with photo diode array and refractive index detectors was used. The analytical method was validated in accordance with regulatory standards, demonstrating high specificity with no interference. It exhibited excellent reproducibility, with a % Relative Standard Deviation of 0.56 in system suitability, and a strong linear correlation (0.999) between concentration and response. The method consistently achieved reliable recovery at all spiked levels with a minimum average recovery of 98.0%, maintaining precision at both method concentration and limit of quantification levels, while demonstrating robustness for intended modifications. The successful validation of this method underscores its potential for extensive implementation in pharmaceutical laboratories.