Development and Validation of HPLC-UV Method for the Determination of a Potent Synthetic Cannabinoid THJ-2201 in Mouse Plasma and Application in a Pharmacokinetic Study

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Author(s): Hassan Y. Aboul-Enein *, Gamal A.E Mostafa*, Haitham AlRabiah, Mohammed Al-Ramadi , Sabry M. Attia, Hebatallah A Wagdy.

Journal Name: Current Pharmaceutical Analysis

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Aim: A new simple and sensitive high-performance liquid chromatography (HPLC) method for the determination of a potent synthetic cannabinoid THJ-2201, has been developed and validated. Lixiviptan was used as the internal standard (IS).

Methods: THJ-2201 and IS were extracted from mouse plasma using deproteinization procedure that uses acetonitrile followed by HPLC analysis. The separation was carried out on a reversed-phase C18 column using water and acetonitrile mixture (30:70 v/v). The flow-rate was 1.0 mL/min. Eluting of both THJ-2201 and lixivaptan was performed at 220 nm.

Results: The method demonstrated linearity over a calibration range of 95 - 1500 ng/mL and the limit of detection (LOD) and quantitation (LOQ) were 28 ng/mL and 91 ng/mL, respectively. The validation of the proposed method was carried out by following the US Food and Drug Administration (FDA) guidelines. Intra- and inter-day precision did not exceed 6.4%, whereas the accuracy of THJ-2201 measurements was within ±13%.

Conclusion: This new method is simple and sensitive and has been applied successfully in a pharmacokinetic study of THJ-2201 in mouse plasma. The mean values of Tmax and Cmax were 0.25 h and 141.87 ± 12.11 ng/mL, respectively.

Keywords: THJ-2201, HPLC, validation, mouse plasma, pharmacokinetic study.

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(E-pub Ahead of Print)
DOI: 10.2174/1573412915666190204144843
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