Journal of Pharmaceutical Analysis and Drug Research ISSN: 3108-0839 (Online)

Authors : Dr. Meenakshi R. Sharma, Dr. Arvind K. Sinha

Abstract: Impurity profiling has emerged as one of the most critical aspects in the pharmaceutical industry to ensure the quality, efficacy, and safety of drug substances. With increasing regulatory demands and advancements in instrumental analysis, hyphenated techniques that combine chromatographic separation with spectroscopic or mass spectrometric detection have gained prominence. These techniques provide high selectivity, sensitivity, and accuracy in identifying and quantifying impurities at trace levels. This paper provides a comprehensive review of the significance of impurity profiling, the principle and application of major hyphenated techniques such as GC-MS, LC-MS, LC-NMR, and CE-MS, as well as their role in modern pharmaceutical analysis. The paper further elaborates on the challenges, limitations, and future prospects of these techniques in achieving reliable impurity characterization.

Keywords: Impurity profiling, Hyphenated techniques, LC-MS, GC-MS, CE MS, LC-NMR, Pharmaceutical analysis, Drug safety