Esra DEMİRTÜRK, Emirhan NEMUTLU, Selma ŞAHİN, Levent ÖNER

Development and validation of an HPLC method for determination of rofecoxib in bovine serum albumin microspheres

A simple and reliable HPLC method was developed and validated for determination of rofecoxib in bovine serum albumin microsphere. The analyses were performed on a C18 column 150 x 4.6 mm, 5 μm particle size at room temperature with UV detection at 272 nm. The mobile phase was composed of acetonitrile-0.1% o-phosphoric acid solution in water 1:1, v/v mixture, and flow rate was set to 1 mL/min. The method was validated according to the international guidelines with respect to stability, linearity range, limit of quantitation and detection, precision, accuracy, specificity, and robustness. The detection and quantification limit of the method were 1.0 μg/mL and 2.5 μg/mL, respectively. The method was linear in the range of 2.5-25 μg/mL with excellent determination coefficients R$^{2\, }$ >0.99 . Intra-day and inter-day precision

Keywords:

Rofecoxib, microspheres, HPLC, validation,

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