Chromatographic Estimation of a Novel Triple-Therapy Combination Targeting Helicobacter Pylori Eradication in Different Matrices

Abstract

Aim: Helicobacter pyloriinfection is a prevalent global bacterial infection that can potentially exaggerate symptoms of other serious infections like SARS-CoV-2 (COVID-19). Methodology: Herein, an efficient, accurate and cost-effectivehigh-performance liquid chromatography-diode array detectormethod was developed and validated for determination of the novel triple therapy combination of tinidazole (TD), clarithromycin (CLR) and lansoprazole (LAN) in different analytical matrices (pharmaceutical formulation, dissolution media and spiked human plasma). Results: Successful chromatographic separation was achieved using Agilent Microsorb-MV 100–5 CN column (250×4.6mm, 5μm) and a mobile phase consisted of acetonitrile and 10.0mM phosphate buffer, pH 7.5±0.1 at flow rate of 1ml/min via gradient elution. UV-detection was accomplished at 210.0nm for CLR and 290.0nm for TD and LAN. Conclusion: The developed method clearly provides a reliable, beneficial and cost-effective tool for quality control, dissolution testing and biological applications of the mentioned drugs.

Keywords::

• dissolution testing
• Helicobacter pylori infection
• HPLC-DAD
• human plasma
• triple-therapy combination

Supplementary data

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Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.