Utilization of UPLC and Empower 2 CDS for Efficient Method Development of an Impurity Profile of Simvastatin and Related Impurities

Library Number:

720002185EN

Part Number:

720002185EN

Author(s):

Michael Jones, Paul Lefebvre, Rob Plumb (Waters)

Source:

Waters Applications Note

Content Type:

Application Notes

Content Subtype:

Application Notes

Related Products:

Empower 2

ACQUITY UPLC System

Empower 2

Small Molecule Method Development

Impurity Profiling with HRMS

Abstract / Summary

In this application, we show how the HPLC method for simvastatin has been redeveloped on UPLC and is compatible for MS. The analytical goals were to meet the requirements stated in the USP 30 - NF 25 monograph for simvastatin drug substance for chromatographic purity and possibly be used for the assay. Empower 2 custom reporting, custom fields, and spectral analysis were used in streamlining the decision making process during method development. The utilization of the ACQUITY UPLC system and Empower 2 software provided a timely solution to the method development challenges associated with impurity profiling.

Downloadable File(s)

Title	Format	File Size
720002185en	PDF	1784.82kB