In Vitro Consistency Evaluation Between Generic and Original TS-1 Preparations

OBJECTIVE To establish a method for the determination of in vitro dissolution curve of TS-1 preparations and to evaluate the consistency of in vitro dissolution curve between 10 domestic TS-1 generics and the original preparation. METHODS Quantitative method for the determination of tegafluorogen(FT), gemiracil(CDHP) and oteracil potassium(OXO) was established by HPLC. The column was Agilent ZORBAX SB-C₁₈. The mobile phase was consist of phosphate buffer and acetonitrile(90:10) with a flow rate of 1 mL·min^-1 under isaratic elution. The detection wavelength was 240 nm at 0-5 min, 288 nm at 5-9 min, and 270 nm at 9-14 min. Sample injection volume was 10 μL. The standard dissolution curves of each preparation in four different dissolution media, namely pH 1.2 hydrochloric acid solution, pH 4.5 acetate buffer, pH 6.8 phosphate buffer and water, were determined by the basket method. The similarity between the dissolution curves of the generic drug and the original drug were evaluated by the similarity factor(f₂). RESULTS The dissolution behavior of 8 domestic TS-1 generics was consistent with that of the original preparation. CONCLUSION The established method can efficiently determine the dissolution curve and provide reference for the quality consistency evaluation of TS-1 preparations.