Determination of NTTP in Sitagliptin by LCMS-8045

User Benefits

>This method exhibits high sensitivity with a quantitation limit of 5 ng/day, significantly surpassing the acceptable intake limit of37 ng/day. >The pretreatment process for this method is straightforward and easy to perform, requiring only ultrasonication.

Introduction

Sitagliptin phosphate is designed for patients with type 2 diabetes and can be used alongside metformin. This compound functions as a dipeptidyl peptidase-4 (DPP-4) inhibitor, which enhances the naturally occurring incretin by suppressing the enzyme's activity, ultimately leading to a reduction in blood glucose concentration. However, the US Food and Drug Administration (FDA) discovered the presence of a genotoxic impurity, NTTP, in some samples of sitagliptin. Consequently, it mandated that relevant companies conduct rigorous testing on their products. The FDA has established strict guidelines, stipulating that the short-term acceptable intake (AI) limit of NTTP in sitagliptin should not exceed 246.7 ng/day, while the lifetime exposure AI limit is set at 37 ng/day. To ensure compliance with these regulations, a method for analyzing NTTP in sitagliptin was developed utilizing the LCMS-8045 triple quadrupole tandem mass spectrometry system. This method demonstrates remarkable sensitivity, surpassing even the 37 ng/day limit, and boasts excellent system adaptability and accuracy. It is thus ideal for routine analysis of NTTP in both raw materials and formulations of sitagliptin.

June 18, 2024 GMT