Thermodynamic Study of Thermal Decomposition of Ranitidine by HPTLC

Abstract

& A thin-layer chromatography (TLC) technique was used to separate the thermal decomposition product of ranitidine hydrochloride. Three samples of standard were heated in thermostat for 5 d in 60 C, 8 d in 80 C, and 2 hr in 100 C. The reagents used as mobile phases were: dimethyl sulfoxide (DMSO), acetonitrile, methanol, 25% ammonia, 2-propanol, and 2-methoxyethanol in a wide range of concentrations 0-100% (v=v). Silica gel 60 F 254 HPTLC plates acted as the stationary phase. The usefulness of various mobile phases to separate ranitidine and products of its thermal decomposition was demonstrated as well as the thermodynamic dependence has been shown.

Trace Level Quantification of 4-Methyl-1-nitrosopiperazin in Rifampicin Capsules by LC-MS/MS

“…N- Nitrosodimethylamine (NDMA), a genotoxic impurity, was detected in valsartan in June 2018, while metformin, sartans, ranitidine, and other drugs were later also found to contain genotoxic nitrosamine impurities. Drug contamination by nitrosamine impurities has therefore garnered international attention as a serious drug safety issue ( Nowakowska and Pikul, 2012 ; U.S. Food and Drug Administration, 2019 ; The European Medicines Agency (EMA), 2020 ). The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) M7 guideline clearly states that aflatoxins, N -nitrosamines, and alkyl-azo compounds are special highly carcinogenic genotoxic impurities; hence, they are grouped together as a cohort of concern (CoC) ( ICH, 2020 ).…”