Degradation Profiling of Formoterol Inhalation Product: Isolation and Characterization of Novel Degradant Expending Advanced Chromatography and Spectroscopy Techniques

ABSTRACT Impurities that originate while on degradation need to get identified and characterized during pharmaceutical development in particular to ensure medication safety, efficiency, and quality since they could compromise a medicine's effectiveness or have unfavorable effects. The Formoterol inhalation product were hydrolyzed applying 2 M hydrochloric acid for 180 min at 60°C; 2 M sodium hydroxide for 180 min at 60°C; 10% hydrogen peroxide for 180 min at 60°C; dry heat around 50°C over 180 min; 90% relative humidity over 72 h around 25°C. Formoterol inhalation product stability (forced degradation/real time testing) investigations have consistently shown a peak (at retention time 6.9 min) with concentration over the identification threshold (1.2%). We designated this peak as FMTR‐DP‐1. This FMTR‐DP‐1 was isolated exploiting preparative HPLC and characterized consuming approaches like NMR, LC‐MS and FT‐IR. The FMTR‐DP‐1 was characterized as (R)‐6‐Amino‐2‐((R)‐1‐(4‐methoxyphenyl) propan‐2‐yl)1,2,3,4‐tetrahydro isoquinoline ‐4,7‐diol with molecular formula C 19 H 24 N 2 O 3 and having 328.412 g/mole of molecular mass. It was studied that Pictet–Spengler reaction serves as one of the most favorable routes of producing FMTR‐DP‐1 from formoterol. A probable reaction mechanism associated with FMTR‐DP‐1 synthesis following Pictet–Spengler reaction was put forth. The UHPLC method for FMTR‐DP‐1 evaluation is validated through meticulous assessments. The outcomes affirm the sensitivity, precision, linearity, ruggedness, accuracy, and robustness capabilities of UHPLC method. Formoterol inhalation product FMTR‐DP‐1 analysis may be reliably performed employing the verified UHPLC approach, which makes a substantial contribution to quality control and pharmaceutical research.