Novel RP-HPLC-DAD approach for simultaneous determination of chlorphenoxamine hydrochloride and caffeine with their related substances.

ABSTRACT: Ensuring the quality control of active pharmaceutical ingredients is crucial for drug products being introduced into the market. Even for established drugs, it is necessary to maintain a cutting-edge impurity control system. To analyze caffeine and chlorphenoxamine hydrochloride in their binary mixture, as well as theophylline and chlorphenoxamine N-oxide as related substances, a reversed phase-high performance liquid chromatography combined with a diode array detector system was created. The chromatographic separation was conducted using a C18 X-select Waters® column. The mobile phase consisted of 20.0 mM potassium dihydrogen phosphate modified to pH 3 with o-phosphoric acid and methanol. A gradient elution program was adopted at a flow rate of 1.3 mL/min and detected at a wavelength of 2

SUBMITTER: Ashraf A 

PROVIDER: S-EPMC11264915 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature