Stable Isotope Fingerprinting for Pharmaceutical Authentication

ABSTRACT

The ¹³C stable isotopic composition of 38 pharmaceutical products was investigated for six medicine analgesics classes ibuprofen, diclofenac, paracetamol, metamizole, ketoprofene, and combinations containing paracetamol to evaluate differences between manufacturers and production batches. Complementary measurements were performed by inductively coupled plasma-mass spectrometry. Linear discriminant analysis was applied on experimental obtained data set for differentiation of three investigated drug types. The carbon isotopic compositions were between −32.9 and −22.6‰. The lowest values of ¹³C (mean of −31.3‰) were obtained for metamizole from all six categories of investigated analgesics. The highest δ¹³C values were obtained for diclofenac (mean of −25.9‰). The most accurate elemental predictors were V, Al, Sb, As, Pb, and Mn.

KEYWORDS:

• Inductively coupled plasma-mass spectrometry (ICP-MS)
• linear discriminant analysis
• pharmaceutical
• stable isotope

Additional information

Funding

The financial support for this work was provided by the National Authority for Scientific Research and Innovation, Program NUCLEU, contract no. PN16-300101.