title: A validated enantioselective HPLC assay of dexibuprofen in dexibuprofen tablet formulations.
abstract: A high-performance liquid chromatography-diode array detector (HPLC-DAD) method was developed and validated for the quantitation of dexibuprofen in dexibuprofen tablets using ovomucoid chiral stationary phase (Ultron ES-OVM). The mobile phasewas composed of 0.025 M potassium phosphate dibasic (pH 4.5)-methanol-ethanol (85:10:5 v/v/v). The method was validated for specificity, linearity, range, accuracy, precision and robustness. The method was enantiomerspecific for the determination of dexibuprofen [S-(+)-isomer ibuprofen] in the presence of R-(-)-isomer ibuprofen in bulk drug, pharmaceutical dosage form and under stress degradation. The method was linear over the range 15-35 mg/mL with r² = 0.9995; accuracy and precision were acceptable with %RSD < 2.0%. The method was found to be specific, precise, accurate, robust and stability-indicating, and can be successfully applied for the routine analysis of dexibuprofen in bulk drug and pharmaceutical dosage form.
authors.affiliation: Methodology Department, Research and Development Sector, Sigma Pharmaceutical Industries, 1st Quarter, Mubarak Industrial Zone, Quesna, El Monofeya, Egypt.
authors.forename: Hanan
authors.initials: H
authors.lastname: Awad
authors.forename: Hassan Y
authors.initials: HY
authors.lastname: Aboul-Enein
authors.forename: Sherif
authors.initials: S
authors.lastname: Lashin
mesh_terms: D018712:Analgesics, Non-Narcotic / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D007052:Ibuprofen / Q000031:analogs & derivatives* / Q000032:analysis; D012680:Sensitivity and Specificity; D013237:Stereoisomerism; D013607:Tablets
chemical_list: D018712:Analgesics, Non-Narcotic; D013607:Tablets; C539402:dexibuprofen; D007052:Ibuprofen