Impurity Analysis of Pharmaceutical Products Using Next-Generation LC Column "Shim-pack Arata™ C18"

Introduction

When basic compounds are analyzed in a column packed with general octadecyl silyl (hereinafter, ODS) silica gel, it is known that analytical accuracy is affected by the peak shape. Although a large number of ODS columns with high separation performance have been commercialized in recent years, tailing or other peak shape abnormalities sometimes occur with columns for basic compounds due to the physical properties of the target compound. As an additional problem, the long time required for column equilibration is an issue under low ionic strength acidic mobile phase conditions, for example, when using 0.1% formic acid in water. Because retention time will change over time if column equilibration is inadequate, stable resolution becomes impossible. The Shim-pack Arata C18 column was developed to solve these many problems. Since a satisfactory peak shape can be obtained with a simple system mobile phase, even with ionic compounds, higher analytical accuracy can be expected. This article demonstrates that basic compounds and acidic compounds can be analyzed stably while maintaining a satisfactory peak shape by using the Shim-pack Arata C18 column, and introduces an example of application to impurity analysis of pharmaceuticals.

May 10, 2019 GMT