Determination of related substances of Raceanisodamine tablets by UPLC
OBJECTIVE To determine the related substances of Raceanisodamine tablets by UPLC.METHODS A C18 column was used and 0.01 mol·L-1 potassium dihydrogen phosphate solution(containing 0.15％triethylamine solution,using phosphoric acid to adjust pH to 6.5)-methanol(70:30)as mobile phase,flow rate was set at 0.2 mL·min-1,and the detection wavelength was 220 nm.RESULTS The linear regression equations of raceanisodamine,tropic acid and 6β-hydroxy-3α-tropine atoate(impurity Ⅰ)were Y=2.1391 × 104X+1.4348 × 103,Y=6.9081 × 104X+5.2007 × 104,and Y=4.8162 x 104X-6.6659 x 104,respectively.The linear range of raceanisodamine,tropic acid and impurity Ⅰ were 5.304-106.080 μg·mL-1,5.215-52.150 μg·mL-1 and 5.300-53.000 μg·mL-1,respectively.r were 0.9998,0.9993,and 0.9993(n=6),respectively.The average recovery of tropic acid and impurity Ⅰ were 97.21％and 100.24％with RSD 1.78％and 0.67％.CONCLUSION This method has high accuracy,strong specificity and good repeatability,which can be used to determine the related substances and content of Raceanisodamine tablets.
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