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A Validated Enantioselective HPLC Assay of Dexibuprofen in Dexibuprofen Tablet Formulations

A Validated Enantioselective HPLC Assay of Dexibuprofen in Dexibuprofen Tablet Formulations

Hanan Awad, Hassan Y Aboul-Enein, Sherif Lashin

Biomed Chromatogr. 2012 Apr;26(4):502-6.

PMID: 22493788

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.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP7758114-A	Potassium phosphate dibasic		7758-11-4	Price

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