Highly sensitive LC – MS/MS method for the determination of NDMA, NDEA, NDIPA, NMBA, NEIPA and NDBA in Metformin drug substance


Health Sciences Authority (HSA) of Singapore on 4th December 2019[1] recalled three out of 46
locally marketed Metformin medicines after presence of NDMA “above the
internationally acceptable level” and this came into . Subsequently, both the
US Food and Drug  (FDA) and the European Medicines Agency (EMA) have
released regular updated into their into the causes of medicine contamination.
Metformin (Figure 1) is the -line drug control of high blood sugar levels in patients with type 2
diabetes, particularly people who are overweight.
Here, a single LC-MS/MS method is developed for the quantitation of six nitrosamines namely
NDMA, NDEA, NDIPA, NMBA, NEIPA and NDBA (Figure 2) in Metformin drug



Leave a Reply

Your email address will not be published.