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Abstract

Development and validation of an HPLC method for analysis of etoricoxib in human plasma

Author(s): U Mandal, D Senthil Rajan, A Bose, KV Gowda, A Ghosh, TK Pal
Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata-700 032, India

Correspondence Address:
T K Pal Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata-700 032 India E-mail: [email protected]


A simple high-performance liquid chromatographic method for the determination of etoricoxib in human plasma has been developed. An aliquot quantity of 1 ml plasma sample was taken and 10 ml internal standard was added and mixed. Saturated borate solution of 0.3 ml was added to it and mixed for 1 minute followed by liquid-liquid extraction with ethyl acetate. Organic layer was separated and evaporated to dryness under nitrogen atmosphere at low temperature (below 50°). Residue was reconstituted with 150 µl of mobile phase. During the whole procedure the samples were protected from light. The assay was performed on Hypersil BDS, C18 (150×4.6 mm, 5 m particle size) column, using 10 milimol ammonium acetate buffer:acetonitrile = 65:35 v/v as mobile phase with ultra violet detection at 235 nm. Lower limit of detection was 10 ng/ml and lower limit of quantitation was 20 ng/ml. Maximum between-run precision was 7.94%. Mean extraction recovery was found to be 79.53 to 85.70%. Stability study showed that after three freeze-thaw cycles the loss of three quality control samples were less than 10%. Samples were stable at room temperature for 12 h and at -20° for 3 months. Before injecting onto HPLC system, the processed samples were stable for at least 8 h. The method was used to perform bioequivalence study in human.

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