Development of a Novel LC- MS/MS Method for Detection and Quantification of Tramadol Hydrochloride in Presence of Some Mislabeled Drugs: Application to Counterfeit Study.

Development of a Novel LC- MS/MS Method for Detection and Quantification of Tramadol Hydrochloride in Presence of Some Mislabeled Drugs: Application to Counterfeit Study. Biomed Chromatogr. 2019 Jan 14;:e4486 Authors: Abdel-Megied AM, Badr El-Din KM Abstract Counterfeiting of pharmaceuticals has become a serious problem all over the world particularly in the developing countries. In the present work, a highly sensitive LC-MS/MS method was developed for simultaneous determination of tramadol hydrochloride (TRM) in presence of some previously expected mislabeled drugs such as alprazolam (ALP), diazepam (DIZ), chlorpheniramine maleate (CHR), diphenylhydramine (DIP) and paracetamol (PAR). The prepared samples were analyzed on API 4000 mass spectrometer using Eclipse C18 column (3.5 μm, 4.6× 100 mm). The mobile phase consisting of 0.01% formic acid, acetonitrile and methanol (60:20:20 v/v/v) was pumped with an isocratic elution at a flow rate of 0.7 mL min-1 . The detection was achieved on a triple quadruple tandem mass spectrometer by multiple reactions monitoring (MRM) mode. The proposed method was successfully validated according to ICH guidelines with respect to accuracy, precision, linearity, limit of detection and limit of quantitation. The calibration linear range for TRM, ALP, DIZ, CHR, DIP and PAR was from 5-500 ng mL-1 . The results revealed that the applied method was promising for differentiation of genuine tramadol tablets ...
Source: Biomedical Chromatography : BMC - Category: Biomedical Science Authors: Tags: Biomed Chromatogr Source Type: research