Selective determination of dimenhydrinate in presence of six of its related substances and potential impurities using a direct GC/MS method

Abstract

A novel simple, direct and selective gas chromatography–mass spectrometry (GC/MS) procedure was developed for the determination of the antihistamine drug dimenhydrinate (DMH) in presence of six of its related substances and potential impurities, namely, diphenylmethane, diphenylmethanol, benzophenone, orphenadrine, caffeine and 8-chlorocaffeine. The method involved resolution of the underivatized compounds using a trifluoropropylmethyl polysiloxane (Rtx-200) capillary column and the mass spectrometric detection was carried out in the electron-impact (EI) mode. Excellent baseline separation of DMH and the cited related substances was achieved in less than 15 min. Quantification of the parent drug DMH was based on measuring its peak area. The reliability and analytical performance of the proposed method were validated with respect to linearity, range, precision, accuracy, specificity, robustness, detection and quantification limits. Calibration curve of DMH was linear over the range 50–500 μg/mL with determination coefficient (R2) = 0.9982. The proposed method was successfully applied for the assay of DMH in tablets dosage form with recoveries >96.80%.

Innovative methodologies for identification and qualification of Impurities: An overview of the latest trends on impurity profiling

“…The DMH calibration curve was linear with a measurement coef icient (R2) of between 50-500 µg / mL= 0.9982. For the DMH test in tablets with recoveries > 96.80%, the proposed approach has been used successfully (Belal et al, 2016).…”

Experimentally designed chromatographic method for the simultaneous analysis of dimenhydrinate, cinnarizine and their toxic impurities

“…On the other hand, the DMH and CIN combination is not officially included in any pharmacopeia. The literature review revealed a spectrophotometric, 14 electrochemical 15 and chromatographic [16][17][18] methods for determination of DMH and its impurities. CIN was assayed spectrophotometrically, 19,20 electrochemically 21,22 and by chromatographic methods [23][24][25][26][27][28] either alone or in combination with other drugs and/or impurities.…”

Simultaneous estimation of dimenhydrinate, cinnarizine and their toxic impurities benzophenone and diphenylmethylpiperazine; in silico toxicity profiling of impurities

“…A literature survey revealed that DMH was analyzed by spectrophotometric, 23 electrochemical 24,25 and by chromatographic methods. [26][27][28] Similarly, CIN was determined spectrophotometrically, 29,30 electrochemically 31,32 and by different chromatographic methods [33][34][35][36][37][38][39] either alone or in combination with other drugs and related impurities. On the other hand, DMH and CIN were simultaneously assayed by spectrophotometric, 40,41 TLC-densitometric 42,43 and HPLC 43,44 methods.…”