Development of an eco-friendly HPLC method for the stability indicating assay of binary mixture of ibuprofen and phenylephrine

Abstract

The development and validation of the stability indicating HPLC technique has contributed to the understanding of the stability profile of ibuprofen (IBU) and phenylephrine (PHE). Stability profile was achieved for PHE, the drug was found to be liable to be influenced by stress oxidative conditions. Two oxidative degradates were formed and their structures were confirmed using IR and mass spectrometry. The drugs and degradation products were successfully separated using a a gradient elution method on YMC-C8 column with 0.1% hexanesulfonic acid and acetonitrile as solvents at pH 6.6. The flow rate was 1.0 mL.min− 1, and a diode array detector operating at 220 nm was used for UV detection. The proposed technique has been validated using ICH guidelines and its greenness was assessed according to Analytical Eco Scale metric.