Stability-indicating UPLC method for determining related substances and degradants in dronedarone.

A simple, sensitive and reproducible method was developed on ultra-performance liquid chromatography coupled with photodiode array detection for the quantitative determination of dronedarone hydrochloride (DRO) in drug substance and pharmaceutical dosage forms. The method is applicable for the quantification of related substances and assays of drug substances. Chromatographic separation was achieved on Acquity UPLC BEH C8 100 mm, 2.

Rapid quantitative determination of related substances and degradants in milnacipran.

A simple, sensitive, precise and accurate stability-indicating ultra-performance liquid chromatography (UPLC) method was developed for the quantitative determination of the purity of the active pharmaceutical ingredient of milnacipran hydrochloride (MCP) and its pharmaceutical dosage form in the presence of its process-related impurities and degradation products. The proposed UPLC method utilizes Acquity UPLC BEH 100 mm, 2.1 mm and 1.