Analysis of Irbesartan Using an Integrated LC System - Nexera^TM-i MT

Introduction

Ultra-high performance liquid chromatographs (UHPLC) are becoming more common in recent years and there will likely be more cases where UHPLC analytical conditions are specified in pharmacopoeias. On the other hand, however, the popularity of UHPLCs is still small in the manufacturing sector for quality control department and makes up only 9 % of the total UHPLC market in contrast to the R&D sector's 38 %. For this reason, applying the analytical conditions specified in the pharmacopoeias may not be adequate for quality control department. Irbesartan and amlodipine besilate tablets are newly listed in Supplement 1 to the 17th Edition of the Japanese Pharmacopoeia (JP), which specifies a column packing particle size of 2.2 μm meaning that a UHPLC needs to be used. Due to the pressure tolerance of the instrument, applying the analytical conditions may not be possible as described. Under such circumstances, Notification No. 0331-1, issued by the Director of the Evaluation and Licensing Division, Pharmaceutical Safety and Environmental Health Bureau, MHLW, states that, on the understanding that the monograph of the drug being tested shall be revised, an application for approval of such drugs is possible by employing analytical conditions using conventional liquid chromatography on the basis of appropriate analytical validation data. The notification is considered to be indicating that it is acceptable to change the JP listed conditions to conventional (HPLC) conditions. This article introduces a system suitability test and analysis using the listed conditions transferred to an HPLC conditions for quantitative determination of irbesartan in irbesartan and amlodipine besilate tablets that are newly listed in Supplement 1 to the 17th Edition of the JP, using a Shimadzu integrated LC system, Nexera-i MT.

July 19, 2018 GMT