A validated isocratic RP-HPLC method for determination of linezolid in pharmaceutical dosage forms

Mustafa, Zana and Memeti, Shaban and Doneva, Dragica and Starkoska, Katerina and Shishovska, Maja and Tanturovski, Zharko and Zulfikjari, Sanija and Dimitrovska, Aleksandra and Arsova-Sarafinovska, Zorica (2022) A validated isocratic RP-HPLC method for determination of linezolid in pharmaceutical dosage forms. Macedonian pharmaceutical bulletin, 68 (1). pp. 99-100. ISSN 1857 - 8969

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Abstract

Linezolid is an oral and parenteral antibiotic that belongs to a new group of synthetic antibiotics known as fluorinated oxazolidinones. Linezolid has been assayed in dosage forms by spectrophotometry, liquid chromatography, high–performance thin–layer chromatography and micellar electrokinetic chromatography (Mohapatra et al., 2011). However, there is yet no monograph on linezolid in the current European Pharmacopoeia. Therefore, we aimed to develop simple, fast and reliable RP-HPLC method for determination of linezolid in dosage forms in the presence of its degradation products. The method performance was further fully validated according to requirements in the ICH Q2(R1) Guideline (ICH, 2019). Chromatographic separation was performed on a reversed-phase column Agilent ZORBAX SB C18 (250 x 4.6 mm I.D., particle size 5 μm), in an isocratic mode. The mobile phase consisted of a mixture of methanol and water acidified with o-phosphoric acid, pH 2.6, 50:50 (V/V). The flow rate was kept at 1.0 mL/min. Wavelength was selected by scanning a standard solution of linezolid over 200–400 nm using Model Lambda 12 (Perkin Elmer) UV-visible spectrophotometer and the wavelength of 254 nm was chosen for detection of linezolid. The injection volume was 20 μL. All separations were performed at a temperature of 30°C ± 2°C. The proposed RP–HPLC method allows simple, accurate and precise determination of linezolid in pharmaceutical dosage forms, in the presence of its degradation products and related compounds. The advantages of the method include short run time, simple sample and mobile phase preparation, isocratic mode of elution, and excellent peak symmetry. Therefore, the developed method can be applied for the routine analysis for determination of linezolid in pharmaceutical dosage forms in quality control laboratories.

Item Type:	Article
Subjects:	Medical and Health Sciences > Health sciences
Divisions:	Faculty of Medical Science
Depositing User:	Zorica Arsova Sarafinovska
Date Deposited:	05 Feb 2023 22:20
Last Modified:	05 Feb 2023 22:20
URI:	https://eprints.ugd.edu.mk/id/eprint/31357

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