High Speed Analysis of Pregabalin in accordance with Chapter 621 in USP 40

Introduction

Many United States Pharmacopeia (USP) monographs were developed using traditional 5 µm column where high flow rates and long runtimes are commonly needed. Such methods require high running cost, long analysis time, and large solvent consumptions. Advance in ultra-high-performance LC and micro-particle column packing material provides a solution to improve productivity and reduce the running cost incurred in USP analysis. USP General Chapter <621> stated the permissible range within which HPLC and GC parameters may be changed. Analysis method can be modified so long as the values are within the permissible ranges and fulfilled the system suitability requirements. Here, we introduced an example of isocratic analysis of Pregabalin monography in compliance with General Chapter 621. Pregabalin is an antiepileptic agent used for neuropathic pain. Shim-pack^TM GIST C18 analytical column, ProminenceTM-i LC-2030C Plus and Nexera^TM X2 system were employed in this application.

March 23, 2020 GMT