Noninvasive detection of counterfeited ampoules of dexamethasone using NIR with confirmation by HPLC-DAD-MS and CE-UV...

Application of near-infrared (NIR) measurements together with chemometric data processing is widely used for counterfeit drug detection. The most difficult counterfeits to detect are the "high quality fakes", which have the proper composition but are produced in violation of technological regulations by underground manufacturers. This study uses such forgeries and addresses important issues. The first is the possibility of applying the NIR/chemometric approach to the detection of injectable formulations of drugs (in this case dexamethasone), which are aqueous solutions with low concentration of active ingredients, directly in the closed ampoules. The second issue is the comparison of NIR/chemometric conclusions with detailed chemical analysis.