High Speed Analysis of Budesonide 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 were commonly needed. Such methods require high solvent consumption and high running cost for instrument and analysis time. 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 ranges within which HPLC and GC parameters may be changed. Analysis method can be modified so long as the values are within the permissible range and fulfilled the system suitability requirements. Here, we introduced an example of isocratic analysis of Budesonide monography in compliance with General Chapter 621. Budesonide is a glucocorticoid used in the management of asthma, the treatment of various skin disorders and allergic rhinitis. Shim-pack^TM GIST C18 analytical column, Prominence^TM-i LC-2030C Plus system were employed in this application.

March 23, 2020 GMT