Method for predicting validity period of esmeprazole enteric-coated tablet

The invention relates to the technical field of medicine validity period prediction, and particularly discloses a method for predicting the validity period of an esmeprazole enteric-coated tablet. Thecontent of impurities with the relative retention time of 0.35 in a high performance liquid chromatogram of the esmeprazole enteric-coated tablet obtained by a related substance detection method in 2015 edition pharmacopoeia is used as an indicator; in different temperature and humidity environments, the indicator content is analyzed to obtain a curve that the impurity content changes along withtime under the corresponding temperature T and humidity RH conditions and a validity period t; and linear regression is performed on 1/T and RH by ln1/t, and the validity period of the esmeprazole enteric-coated tablet at specific storage temperature and humidity is predicted by using an Arrhenius equation for humidity correction. The validity period prediction equation is short in test period, good in repeatability and re