Determi̇nati̇on of proton pump i̇nhi̇bi̇tors by hi̇gh-performance li̇qui̇d chromatography
Abstract
Aim of the work: Analysis of proton pump inhibitors by high-performance liquid chromatography.
Materials and methods. The studies were conducted on the following comparison standard samples and drugs. Standard samples: omeprazole (working standard Lot: B636472_01), pantoprazole (working standard: PANTBP/2023/01), dexlansoprazole (working standard: RLP/0890922). The following drugs were analyzed in the study: Omeprazole 20 mg capsule N30, Pantoprazole 20 mg tablet N28, Dexlansoprazole 30 mg capsule N30. Acetonitrile (Sigma-Aldrich series: I1306730339), triethylamine (Sigma-Aldrich series: S6010152947), 85% phosphoric acid (Merck KGaA, series: K52615773 029) and ultrapurified water were used as working solvents.
Results: The identity and quantity of the main active components included in the composition of omeprazole, pantoprazole and dexlansoprazole preparations were determined by the HPLC method. Optimal chromatographic conditions for the determination of the amount of HPLC in all three preparations were developed and prepared, and the wavelength of 285 nm, injection volume of 10 μl, temperature of 25°C, flow rate of 1.0 ml/min and “Purospher Star RP-8 endcapped” (4.6 x 150 mm, particle size 5 μm) column were determined to be optimal. The proposed method is distinguished by its accuracy, simplicity and short implementation time. The method allows for effective quality control of preparations during their production and use.
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