High Speed Analysis of Cyanocobalamin in compliance with Chapter 621 of USP40

Introduction

Most of the monographs in United States Pharmacopeia (USP) were developed using HPLC with traditional 5 μm column wherein high flow rates and long runtimes are commonly needed. Such methods require high running cost, longer analysis time and solvent consumption. Advances in ultra-high-performance LC and microparticle column packing materials, provide a solution to improve productivity and reduce the running cost incurred in USP analysis. USP General Chapter 621[1] 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 ranges and fulfill the system suitability requirements. Here, we introduced an example of isocratic analysis of cyanocobalamin[2] in compliance with General Chapter 621. Cyanocobalamin is a vitamin and responsible for many body functions. Shim-pack VP-ODS which is categorised as L1 analytical column, Prominence-i LC2030C Plus system and newer coreshell technology column were used in this application.

January 7, 2020 GMT