Validated method for NDMA analysis in pharmaceuticals with high DMF content

Fortis Technologies is excited to bring your attention to a recent publication via the joint collaboration of  analytical groups at Merck - Rahway and NJIT, to scout 10 aqueous compatible HPLC columns for method development with the goal of finding a HPLC column that can provide sufficient separation of NDMA, DMF and the sample matrix in metformin HCL drug products. 

NDMA is a very polar analyte with weak retention on most LC columns.  Another of the challenges of this method is the DMF is often in a high overload state in comparison to the NDMA, leading to co-elution and suppression, potentially even false positives.

To address these issues the authors developed a robust HPLC-MS method employing an Evosphere AQUA column, which enables good separation of NDMA from DMF and other sample matrices. This method permits accurate quantification of NDMA in the presence of DMF at concentrations up to 1,000,000 times greater. 

The method has been successfully validated according to ICH guidelines, demonstrating specificity, sensitivity, accuracy, precision, and robustness.

To learn more about the full method used, download here.

Fortis Technologies is celebrating its 20th anniversary this year, we would like to thank each and every one of our customers who have been with us during this time. We also look forward to many more years of working with new customers to support you in your separation challenges.  Look out for our special promotions and competitions if you see us at the various conferences this year.