The invention discloses a
verification and
separation method for a
terfenadine related substance. The method comprises the following steps: 1) respectively putting 70%
acetonitrile into impurities anda proper amount of TFND (
Terfenadine) so as to obtain a 10mu g / mL single solution, performing full-
wavelength scanning at wavelengths of 190-400nm so as to obtain scanning wavelengths of different substances, and confirming
ultraviolet scanning detection wavelengths; 2) preparing a
mixed solution for detection; 3) setting the following spectrum conditions: a spectrum column: MZ-NALYTICAL Column of 250*4.6mm 100ODS 5mu m; a mobile phase A:
acetonitrile and
phosphate in a ratio of 20:80; a mobile phase B:
acetonitrile;
gradient elution: 0 minute, 60%A, 40% B, 3 minutes, 55%A, 45%B, 20 minutes,20% A and 80%B; a
solvent of acetonitrile and
phosphate in a ratio of 45:55; a
wavelength of 217nm; a flowing velocity of 1.0mL / minute; a
column temperature of 30-35 DEG C; a sampling amount of 20mu L; 4) feeding the
mixed solution as a sample, recording chromatogram, and separating both
terfenadine and different impurities. By adopting the method, the separation degree of the
terfenadine and theimpurities is greater than 5.0, the separation degrees among the impurities and between other known impurities and the terfenadine are both greater than 1.5, in addition, the separation degree of a main peak and unknown impurities can be up to 3.5, and requirements can be met.