title: High performance liquid chromatography with photo diode array for separation and analysis of naproxen and esomeprazole in presence of their chiral impurities: Enantiomeric purity determination in tablets.
abstract: A stereoselective high performance liquid chromatographic method with diode array detection (HPLC-DAD) was introduced for S-naproxen and esomeprazole determination in tablets. The separation was achieved on a Kromasil Cellucoat chiral column using a mobile phase consisting of hexane: isopropanol: trifluoroacetic acid (TFA) (90:9.9:0.1 v/v/v). The proposed system was found to be suitable for the enantioseparation of naproxen and omeprazole biologically active isomers. After optimization of the chromatographic conditions, resolution values of 3.84 and 2.17 could be obtained for naproxen and omeprazole isomers, respectively. The method was fully validated for the determination of S-isomers of each drug in their dosage form. Also, the enentiomeric purity was determined in commercial tablet containing S-naproxen and esomeprazole. The enantiomeric purity was calculated for each drug and the chiral impurities (R-isomers) could be determined at 1% level. The method was validated and good results with respect to linearity, precision, accuracy, selectivity and robustness were obtained. The limits of detection (LOD) and quantification (LOQ) were 2.00, 6.50 and 0.10, 0.35μgmL-1for S-naproxen and esomeprazole, respectively.
authors.affiliation: Faculty of Pharmacy, Department of Pharmaceutical Analytical Chemistry, University of Alexandria, El-Messalah, Alexandria 21521, Egypt. Electronic address: marmed_2001@yahoo.com.
authors.forename: Marwa A A
authors.initials: MAA
authors.lastname: Ragab
authors.affiliation: Faculty of Pharmacy, Department of Pharmaceutical Analytical Chemistry, University of Alexandria, El-Messalah, Alexandria 21521, Egypt.
authors.forename: Eman I
authors.initials: EI
authors.lastname: El-Kimary
mesh_terms: D019840:2-Propanol / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid; D064098:Esomeprazole / Q000032:analysis*; D006586:Hexanes / Q000737:chemistry; D057230:Limit of Detection; D009288:Naproxen / Q000032:analysis*; D009853:Omeprazole / Q000032:analysis; D015203:Reproducibility of Results; D013237:Stereoisomerism; D013607:Tablets / Q000737:chemistry*; D014269:Trifluoroacetic Acid / Q000737:chemistry
chemical_list: D006586:Hexanes; D013607:Tablets; D009288:Naproxen; D014269:Trifluoroacetic Acid; D009853:Omeprazole; D064098:Esomeprazole; D019840:2-Propanol
keywords: Chiral HPLC-DAD; Chiral impurities; Esomeprazole; Naproxen