Forced Degradation Study and Impurity Profiling of Sun API by UPLC-HRM

Abstract

In order to enhance stability representative methodologies that generate excellent stability data and comprehend the degradation routes of the drug ingredients and drug products, forced degradation is a commonly employed approach in pharmaceutical research. Impurities may have unexpected pharmacological or toxicological impacts on the quality, safety, and effectiveness of medications, which is important for pharmaceutical quality control. Intact mass analysis is the measurement of the entire molecular weight of a peptide using mass spectrometry without first digesting the target molecule. When determining the monoisotopic mass of peptides and proteins, which is used to conformate their high molecular masses, high-resolution mass spectrometry is a crucial tool. The forced degradation study was performed on SUN API using several conditions like acid, base, peroxide heat and ammonium bicarbonate and compared with the control sample. All the impurities have been successfully resolved with help of column YMC Pack Pro C18 (250x4.0) mm, 3μm and mobile phase used was buffer 100% and buffer: acetonitrile (1000:1000). The highest degradation was observed in alkali conditions where 4 impurities were generated. The percentage purity of the control sample was 99.07% and the percentage purity of the alkali, acid, peroxide, thermal and ammonium bicarbonate samples was 51.91%, 83%, 99.11%, 90.98% and 78% respectively. The associated advantages of High-Resolution Mass Spectrometry (HRMS) make it an invaluable analytical tool for analyte characterization, screening, and quantification methodologies for a wide scope of applications across pharmaceutical development. These applications include drug discovery, product characterizations of both small molecules and novel drug modalities, in vitro and in vivo metabolism studies, post-approval quality control, and pharmacovigilance.