The invention discloses a method for measuring degraded impurities in
orlistat capsules and relates to the field of
analytical chemistry.According to the method, a high performance liquid chromatographic method is adopted, an
impurity mixed reference substance solution and a sample solution are injected in a high performance liquid chromatograph, and measurement of the degraded impurities in the
orlistat capsules is completed.According to the chromatographic conditions,
silica gel solid sphere particles are used as filler of a
chromatographic column; a mobile phase A is an acidic water solution, a mobile phase B is an
organic solvent, the sum of the percent by volume of the mobile phase A and the percent by volume of the mobile phase B is kept 100% all the time, and
linear gradient elution is carried out.According to the method, the Cortecs C18 (Waters, 150 mm*4.6 mm, 2.7 micrometers)
chromatographic column is adopted, and by optimizing the mobile
phase gradient elution procedure, all the degraded impurities and process impurities hard to separate nearby a main peak can be separated under the same chromatographic conditions, and the degraded impurities in the
orlistat capsules can be effectively detected.