A new accurate and sensitive RP-HPLC method has been developed and validated for the analysis of triamcinolone in human plasma for its bioequivalence studies. In the method, 0.5 % triethylamine (TEA) (pH 3.48) and acetonitrile in the ratio of 50:50 v/v was used as mobile phase at 1 mL/min flow rate and the Thermo C18 column was used as stationary phase. Protein precipitation technique was used for plasma extraction and the extraction recovery was achieved as 79.5 % using 5 % of trichloroacetic acid. The drug was eluted at 4.9 min. and no plasma endogenous materials were observed in the retention time. The limit of quantitation (LOQ) of the method was calculated as 100 ng/mL and the linearity was in the range of 0.5-15.0 μg/mL. R2 of the calibration curve was found as 0.999. The proposed method shows a good accuracy, precision and linearity and, it can be used for the bioequivalence studies of triamcinolone.
Keywords: Triamcinolone, Human plasma, HPLC, Optimization, Validation