Method for determining content of impurities in isonicotinamide albendamide by utilizing HPLC (High Performance Liquid Chromatography)

• Main Authors: ZUO SHUAI, GENG YAN, GAO ZHENG, ZHOU JU, XU WEI, GU LI, WEI ZHENG
• Format: Patent
• Language: Chinese; English
• Published: 20.01.2023
• Subjects: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES; MEASURING; PHYSICS; TESTING

The invention discloses a method for determining the content of impurities in isonicotinamide albendamide by utilizing HPLC (High Performance Liquid Chromatography), and belongs to the technical field of pharmaceutical analysis. The impurities in the isonicotinamide propyl sulfide comprise 4-cyanopyridine, 2-propyl-4-cyanopyridine, isosulfamide, 2-propyl isonicotinamide and isonicotinamide ethyl sulfide; comprising the following steps: 1) preparing a test solution and a contrast solution; 2) setting high performance liquid detection conditions: a chromatographic column takes octadecyl bonded silica gel as a filler, the specification is 250mm * 4.6 mm, the particle size of the filler is 5 microns, the column temperature is 35 DEG C, buffer salt is taken as a mobile phase A, and acetonitrile is taken as a mobile phase B; carrying out gradient elution at the flow rate of 1.0 mL/min; and 3) respectively and precisely sucking the test solution and the contrast solution, injecting into a liquid chromatograph, and r