Abstract
BackgroundA receptive and easily comprehended technique was evolved for simultaneous assessment of Bempedoic acid and Ezetimibe and its impurities characterized by UPLC–MS/MS.ResultsThis technique involves chromatographic separation with a C18 column of water symmetry (150 mm × 4.6 mm, 3.5 µm). A mobile phase of 0.1% OPA (orthophosphoric acid) and acetonitrile in 50:50 v/v with 1 mL/min flow rate and ambient temperature was used. UV observation was taken at 230 nm. The recoveries, linearity, and quantification limits were found to be within the acceptable limit.ConclusionsThis technique was successfully tested with UPLC–MS to confirm the chemical structures of newly formed degradation products of Bempedoic acid and Ezetimibe and stress studies as per ICH Q2 (R1) guidelines.
Highlights
A receptive and comprehended technique was evolved for simultaneous assessment of Bempedoic acid and Ezetimibe and its impurities characterized by Ultra-performance liquid chromatography (UPLC)–MS/MS
An isocratic elution of Bempedoic acid and Ezetimibe involved symmetry C18 column with a flow rate of 1 mL/ min, and ambient temperature was maintained within the column
System suitability The standard solution of Bempedoic acid (180 μg/mL) and Ezetimibe (10 μg/mL) was injected into the UPLC system, and the chromatogram of UPLC is shown in Fig. 2. %RSD was calculated by using the peak areas, and the results were found to be within the acceptable limit
Summary
A receptive and comprehended technique was evolved for simultaneous assessment of Bempedoic acid and Ezetimibe and its impurities characterized by UPLC–MS/MS. The most common adverse effects in clinical trials are muscle spasms, pain in the rear or within the limb, gout [11, 12], and gastrointestinal problems [13] like diarrhea [14, 15]. Ezetimibe is a pharmaceutical drug unused and treats high blood cholesterol and certain other lipid abnormalities. It is used alongside dietary changes and a statin [18, 19]. Serious side effects include anaphylaxis [20, 21], liver problems, depression, and muscle breakdown. The experiments provided details on the conditions under which the drug was unstable to Vejendla et al Future Journal of Pharmaceutical Sciences (2021) 7:234
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