Analysis of Montelukast Sodium Using Prominence-i and Nexera-i MT

Introduction

Montelukast sodium is used as a therapeutic drug for treating bronchial asthma and allergic rhinitis, and is listed in the 17th edition of the Japanese Pharmacopoeia (JP). The JP is aiming for international harmonization with the US Pharmacopoeia (USP) and European Pharmacopoeia (EP), and descriptions for this drug have already been harmonized between the USP and EP. Therefore, the testing methods described in the JP are based on this harmonized content. Structural formulae of impurities and flow rates used for analysis are clearly indicated, showing how the tests should be from now on. This article introduces system suitability tests of montelukast sodium using Prominence-i and Nexera-i MT in compliance with the 17th edition of the JP.

July 12, 2017 GMT