Analysis of Cyanocobalamin tablets, assay procedure 2 as per USP41-NF36 monograph, using Shimadzu Nexera X2 Fast LC system

Introduction

Cyanocobalamin tablets (1000mcg) is a prescription and over-the-counter (OTC) synthetic form of vitamin B12 used to prevent and treat low blood levels of vitamin B12. Vitamin B12 is the "generic descriptor" name for any vitamers of vitamin B12.Since, humans and animals can convert cyanocobalamin to any one of the active vitamin B12 compounds, by definition this makes cyanocobalamin itself a form(or vitamer) of B12. USP41-NF36 monograph for cyanocobalamin tablet defines a UHPLC method for high throughput fast analysis demanding a competent UHPLC system. Here, we demonstrate the analysis of cyanocobalamin tablets as per USP41-NF36 monograph 1114, procedure 2 performed on Shimadzu Nexera X2 fast LC system in compliance with system suitability requirements of USP monograph within the permissible limits of USP chapter 621. Shimadzu Nexera X2 system increases the potential of UHPLC analysis by, Maximizing Analytical Reliability Micro-volume plungers providing precise solvent delivery and low injection volumes to achieve excellent injection reproducibility and extremely low carryover. Maximizing Throughput With a pressure range up to 130 MPa, high-speed injection, overlapping injection and highly efficient gradient mixing, Nexera enables ultra-high speed and ultra-high resolution analysis. Maximizing Expandability Column oven and autosampler, along with the modular flexibility of the system, expand the application ranging from high-temperature analysis, green LC, auto-sample pretreatment to multidimensional LC separation.

January 7, 2020 GMT