La mise au point d’une méthode d’analyse de l’oméprazole par spectrophotométrie extractive

Abstract

In the pharmaceutical industry, the analytical validation of a method constitutes an important part of a quality system in the objective of having a reliable and exact method that is suitable for the uses for which it is intended. . The analytical validation allows for a sufficiently reliable procedure and taken with all confidence and to have results within the acceptance limits. In this work we were interested in the study of the development and analytical validation of a dosage method as well as the quality control of the finished product which ensures its: safety, efficiency, security and its compliance with requirements and to illustrate these approaches Omeprazole was chosen for study. The UV-VISIBLE spectrophotometric analysis technique was chosen as being the most suitable method given its simplicity, specificity and sensitivity to characterize and demonstrate the follow-up of the omeprazole extraction operation using a colorimetric method after extraction of the molecule by formation of ion pairs with an acid-base dye using organic solvent chloroform.