The invention discloses an
analysis method for determining related substances in a
glimepiride intermediate by utilizing HPLC (
High Performance Liquid Chromatography), and particularly relates to an
HPLC analysis method for the
glimepiride intermediate and four impurities in the
glimepiride intermediate. According to the present invention, with the
chromatographic column type and specification, the detection
wavelength, the mobile phase type, the mobile
phase ratio, the
operation time and the like, the impurities in the glimepiride intermediate can be rapidly, simply, accurately and efficiently eluted, separated and quantitatively detected, the complete separation between the
impurity peak and the main peak and the complete separation between the impurities and the
impurity peaks can be achieved, and the optimal detection result can be achieved; and the
analysis method is convenient to operate, short in
running time, high in specificity, sensitivity and stability, has a better linear curve in a low concentration range, has higher
repeatability and accuracy, is not influenced by personnel and instruments, is stable and reliable, and provides a basis for research, development and quality detection of the compounds.