A stability-indicating green RP-HPLC method for single-run quantification of ten related substances and abrocitinib,...

A robust stability-indicating green reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the quantitative analysis of abrocitinib and its ten related substances in accordance with green analytical chemistry principles. The developed method demonstrated simultaneous separation of 11 analytes and this high-performance multi analyte separation truly built on column chemistry principles, delivering complete baseline resolution with USP-compliant system suitability parameters prior to the validation. Chromatographic separation was achieved on an octadecylsilane stationary phase environment using a Waters 2998 photodiode array detector at 210 nm. The mobile phase consisted of 0.1% perchloric acid in water and acetonitrile:water (90:10, v/v) under gradient elution. The method effectively separated degradation products formed under different types of solid & liquid state stress conditions, confirming its stability-indicating capability. The developed RP-HPLC method further validated which has demonstrated reliability, specificity, linearity and other validation parameters as per International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q2(R1) guidelines for routine quality control analysis of abrocitinib and related substances while aligning with the 12 principles of green analytical chemistry.