Identification and simultaneous quantification of potential genotoxic impurities in first-line HIV drug dolutegravir sodium using fast ultrasonication-assisted extraction method coupled with GC-MS and in-silico toxicity assessment.

Dolutegravir (DLG) has become a distinctive first-line antiretroviral therapy for the treatment of HIV in most countries due to its affordability, high efficacy, and low drug-drug interactions. However, the evaluation of genotoxic impurities (GTIs) in DLG and their toxicity assessment has not been explored thoroughly. Thus, in this study, a simple, fast, and selective analytical methodology was developed for the identification and determination of 7 GTIs in the comprehensive, explicit route of synthesis for the dolutegravir sodium (DLG-Na) drug.

Functional group-specific multilateral derivatization cum extraction method for simultaneous quantification of genotoxic impurities in carvedilol phosphate drug using GC-MS and their toxicity assessments.

A simple and facile functional group-specific multilateral derivatization cum extraction method coupled with GC-MS based analytical methodology has been developed for the rapid identification and determination of five potential genotoxic impurities (GTIs), including epichlorohydrin, hydrazine, phenylhydrazine, 3-chloro-1,2-propanediol and 1-(2-chloroethoxy)- 2-methoxybenzene in the carvedilol phosphate (CRV-P) drug active pharmaceutical ingredient (API). A generic synthetic route has been explored to apply the current investigation to the majority of the market available synthetic routes for the carvedilol process. Five significant GTIs were identified, and their toxicity was examined using in-silico model.

Identification and characterization of unknown degradation impurities in beclomethasone dipropionate cream formulation using HPLC, ESI-MS and NMR.

The present study focuses on identifying the degradation profile and pathways of unknown impurities from beclomethasone dipropionate (BDP) topical cream formulation reported under accelerated stability conditions. Six degradation impurities were observed during the accelerated stability testing of BDP topical cream formulation, and these thermally labile degradation impurities were primarily identified using a simple, effective and mass compatible isocratic reversed-phase high-performance liquid chromatography with ultraviolet detection method. The degradation impurities found in this sample were of very low concentration levels, thus the concentration of these impurities in the sample was enriched by mimicking the thermal degradation conditions to structurally elucidate the unknown impurities.