Analysis of Impurities in Pharmaceutical Ingredients Using Trap-Free Two-Dimensional HPLC and Triple Quadrupole LC/MS/MS (LCMS-8040)

Introduction

Controlling and confirming trace impurities contained in products in terms of the type, quantity, and safety has become an increasingly important issue to guarantee the product quality in a wide range of fields, including drugs (final formulations and raw materials, generic drugs), foods (health foods, supplements), and fine chemical products (solvents, paints, surfactants, many other synthetic products). Mass spectrometers, such as triple quadrupole LC/MS/ MS instruments, have been attracting attention as a useful means of measuring trace impurities in products. However, its widespread adoption has been complicated by the fact that HPLC-UV methods, which are commonly used for impurity analysis, use non- volatile mobile phase conditions incompatible with LC/ MS analysis. To address this problem, laboratories have attempted to modify these methods to make them compatible with LC/MS. However, due to the risk and difficulty associated with changing method conditions, including changing the order of elution and missing impurities that elute near the principle component, very careful consideration is required. In this report, we introduce an example of analysis in which trap-free two-dimensional HPLC was used to detect impurities using non-volatile mobile phase conditions, which were then converted without complication to volatile mobile phase conditions online to complete the analysis using the LCMS-8040 triple quadrupole mass spectrometer.

November 27, 2014 GMT