The first validated stability-indicating HPLC/DAD method for quantitation of Vericiguat in its pharmaceutical formulation; Application to degradation kinetic studies

The stability of innovative drug formulations and the development of appropriate stability-indicating methods remain major focuses of recent pharmaceutical analysis. In the present study, an efficient stability-indicating HPLC-DAD technique has been described and validated for the determination of V...

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Bibliographic Details
Published in:Talanta (Oxford) 2023-07, Vol.259, p.124498-124498, Article 124498
Main Authors: Mustafa, Doaa M., Magdy, Nancy, El Azab, Noha F.
Format: Article
Language:English
Subjects:
Chromatography, High Pressure Liquid - methods
Degradation
Drug Compounding
HPLC-DAD
Kinetic study
Kinetics
Stability
Validation
Vericiguat
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Summary:The stability of innovative drug formulations and the development of appropriate stability-indicating methods remain major focuses of recent pharmaceutical analysis. In the present study, an efficient stability-indicating HPLC-DAD technique has been described and validated for the determination of Vericiguat (VER); a novel oral soluble guanylate cyclase (sGC) stimulator used in heart failure. VER's stability under various stress conditions was examined. It was shown that VER was sensitive to alkaline, oxidative and thermal degradation. Mass spectrometry (MS) in electrospray ionization mode was performed to figure out the structure of the alkaline and oxidative degradation products. Efficient separation of VER and its induced degradation products was accomplished using isocratic elution mode on the Inertsil ODS-C18 column. The mobile phase composed of water: acetonitrile (70:30 v/v) with 0.1% O-phosphoric acid; pH was adjusted to 2.22 and a flow rate of 0.80 mL/min. VER was detected at 332 nm over a concentration range of 2.00–20.00 μg/mL. The retention time was 4.500 ± 0.005 min and the correlation coefficient was 0.9996. Following the International Conference of Harmonization's guidelines, the analysis was validated to be specific, fast, simple, precise and accurate for utilization in routine analysis and quality control of VER in its pharmaceutical formulation. Additionally, the suggested technique was expanded to investigate the kinetics of alkaline, oxidative and dry heat degradation. [Display omitted] •The first stability-indicating method for estimation of Vericiguat has been established•Vericiguat was stable to acidic and photolytic hydrolysis, but sensitive to alkaline, oxidative and thermal stress degradation•Chemical structure of alkaline and oxidative degradation products and degradation pathways were proposed•Kinetic studies were conducted for degradation of Vericiguat which all proved to follow a first order•This represents the first HPLC method for Vericiguat analysis in dosage forms
ISSN:0039-9140
1873-3573
DOI:10.1016/j.talanta.2023.124498