Coupling of Physical and Chromatographic Separation for Analyzing Cream Containing Miconazole, Mometasone Furoate and Gentamicin Sulphate.

Autor: Tawakkol SM; Pharmaceutical Chemistry Department, Faculty of Pharmacy, Ahram Canadian University, Banks complex, 4th industrial zone, 6th October City, Giza governorate 12451, Egypt., Fayez YM; Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Al kasr Al Aini St, Cairo governorate 11562, Egypt., Fahmy NM; Pharmaceutical Chemistry Department, Faculty of Pharmacy, Ahram Canadian University, Banks complex, 4th industrial zone, 6th October City, Giza governorate 12451, Egypt., Lotfy HM; Pharmaceutical Chemistry Department, Faculty of Pharmacy, Future University in Egypt, Cairo, End of 90's St, Cairo governorate 11835, Egypt., Shehata MA; Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Al kasr Al Aini St, Cairo governorate 11562, Egypt.
Jazyk: angličtina
Zdroj: Journal of chromatographic science [J Chromatogr Sci] 2023 Apr 24; Vol. 61 (4), pp. 347-357.
DOI: 10.1093/chromsci/bmac063
Abstrakt: High-performance liquid chromatographic method was developed, validated and applied for miconazole, mometasone and gentamicin in Momenta® cream. Physical separation was applied using two extraction procedures due to different solubility of the three components. First, a methanolic extract of the cream contained miconazole and mometasone was chromatographed on ODS-3 Inertsil C18 column (150 × 4.6, 5 μm) using acetonitrile: water (80:20, v/v) as a mobile phase, flow rate 1.5 mL·min-1, scanned at 230 nm, showing tR 2.817 and 6.808 min for mometasone and miconazole, respectively. Second, an aqueous extract of the cream containing gentamicin was derivatized with o-phthalaldehyde in order to enhance the gentamicin UV detection and subjected to ion pairing chromatography on Inertsil ODS-3 C18 column (150 × 4.6, 5 μm), using methanol: 0.025 M heptane sulphonic acid: glacial acetic acid (75:20:5, by volume) as a mobile phase, flow rate 0.8 mL·min-1, scanned at 330 nm where the three active gentamicin isomers were separated at tR 11.7, 15.6 and 18.3 min. Suitability of this method for quantitative estimation of the drugs was proved by validation according to ICH guidelines. The method was selective, precise and accurate so could be used for analysis of cream formulation in QC labs.
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Databáze: MEDLINE