Simultaneously Detecting of 13 Kinds of Illegal Hpyerglycemic Additives in Chinese Patent Drug by HPLC

OBJECTIVE To construct an approach which can be used to assess the concentration of 13 illegal chemical hypoglycemic additives in Chinese patent drug simultaneously.METHODS HPLC-DAD was employed in this research.CAPCELL PAK C₁₈ column(4.6 mm×250 mm, 5 μm) was used. The samples were eluted by methanolsodium dodecyl sulfate solution with gradient concentration. DAD detector was used with wavelength of 235 nm. Different forms of Chinese patent drug were analyzed, which included tablets, granules, pills, capsules and oral solution. The samples were extracted using methanol.Qualitative results were determined using retention time and ultraviolet spectrum. Quantitative results were obtained via external standard method based on the area of absorption peak. The positive samples were verified using UPLC-MS(ES1, positive ion mode, SRM scanning).RESULTS The 13 hypoglycemic chemicals were completely separated. The linearity were good when the concentration in the range of 0.5-20 μg·mL^-1. The recoveries rate were 94.36%-104.30% with RSDs of 0.5%-3.2%. One batch of samples were tested positive, which was verified using UPLC-MS.CONCLUSION The method is timesaving and reliable, which is suitable for daily drug controlling supervision.