β-carboline and canthinone alkaloids are widely distributed in the Angiosperms. Due to their diverse biological activities, the structures of these alkaloids have been used as important models for the synthesis of novel therapeutic drugs. Combining highperformance liquid chromatography (HPLC) with high-resolution mass spectrometry (HRMS) has provided a valuable tool in the analysis of these alkaloids in, for example, plants, insects, marine creatures, human tissues and body fluids. In this review, we summarized the main β-carboline and canthinone alkaloids studied by liquid chromatography high-resolution mass spectrometry (LC-HRMS) associated with mass analyzers, molecular weight information, mass fragmentation and biological activities, presenting an overview of increasing interest for carboline alkaloids study by LC-HRMS.
This study aimed to develop a reliable stability-indicating method (SIM) for amoxicillin 500 mg capsules (DP-drug product). A literature review addressing amoxicillin (AMX; DS-drug substance) forced degradation studies and the existing SIMs was conducted to verify the most significant outcomes. Subsequently, the forced degradation of DP and DS was carried out following the Brazilian Health Surveillance Agency (ANVISA) guidelines, including thermal degradation (dry and wet heat), acidic and alkaline hydrolyses, hydrogen peroxide oxidation, reaction with copper, and photodegradation. Both DS and DP were more susceptible to 0.015 M NaOH, resulting in approximately 50% degradation. AMX DS and DP were not significantly photodegraded, but some degradation products (PDegs) showed susceptibility to light exposure. Thermodegraded samples showing ≥ 10% degradation exhibited modified profiles in thermogravimetric (TG) and differential scanning calorimetric (DSC) analyses. The X-ray powder diffraction patterns (XRPD) of DS samples exposed to dry and wet heat displayed complete amorphization of AMX, attesting to the occurrence of physical degradation concomitantly with chemical degradation, which can alter the drug’s bioavailability. In contrast, the thermodegraded DP samples exhibited intact AMX crystals interspersed with the amorphous form, perhaps partly protected by the excipient. The validated SIM was able to detect and quantify about 80 PDegs.
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