Separation and Characterization of the Related Substances of Bedaquiline Fumarate Using HPLC and Spectral Methods.

The study focuses on isolating and characterizing the potential degradation products (DPs) and impurities of Bedaquiline fumarate in bulk drug form. A stability-indicating related substance method was developed and validated using high-performance liquid chromatography. Agilent Poroshell 120EC- C18 (150 mm × 4.

Isolation and characterization of thermal degradation impurity in brimonidine tartrate by HPLC, LC-MS/MS, and 2DNMR.

One potential unknown impurity was detected during the analysis of stability batches of brimonidine tartrate (BMT) in the level ranging from 0.03 % to 0.06 % by high-performance liquid chromatography (HPLC).

Identification and characterization of Prothionamide degradation impurities by mass spectrometry, NMR spectroscopy, and ultra high performance liquid chromatography method development.

Stability-indicating and liquid chromatography-mass spectrometry compatible ultra high performance liquid chromatography method was developed for the degradation and drug substances related impurities of Prothionamide. Forced degradation of Prothionamide was carried out under acidic, basic, thermal, oxidative, and photolytic stress conditions. The impurities separation was achieved on Acquity UPLC BEH-C18 (50 mm × 2.