Updating HPLC Compendial Methods in Pharmaceutical Analysis

Summary

I.     Compendial methods in Pharmaceutical Analysis

Manufacturers of generic drugs must prove that the generic compounds they produce are comparable to originator-brand name drugs. In addition, these generic drugs need to be manufactured in a way to maintain or lower the cost of the drugs production.

As a result, these modified methods become a important part of their processes. One of the ways to decrease costs is to 'adjust' compendial methods, which in many cases are written by using 5-micron columns to develop the original method. Thanks to USP <621> and EP11.0 updates, the latest development in LC column technology columns (Superficially Porous Particle) can be used to modernize the existing compendial methods. In some cases, paths to method adjustment are clear and easy. In other cases, a bit more work needs to be done.

II.   Strategically Selecting the Best LC Column for your Method Development

The proper columns and mobile phases will ensure speedy, robust method development for your analysis.  Using these with the correct instrument setup and sample preparation can further ensure that you get the most from your high efficiency superficially porous InfinityLab Poroshell columns.