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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

Author(s):

Hassan Y. Aboul-Enein *, Gamal A.E Mostafa*, Haitham AlRabiah, Mohammed Al-Ramadi , Sabry M. Attia and Hebatallah A Wagdy   Pages 1 - 8 ( 8 )

Abstract:


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.

Affiliation:

Pharmaceutical and Medicinal Chemistry Department, Pharmaceutical and Drug Industries Research Division, National Research Center, Dokki, Cairo 12622, Pharmaceutical Chemistry Department, College of Pharmacy, King Saud University, P.O.Box 2457, Riyadh 11451, Pharmaceutical Chemistry Department, College of Pharmacy, King Saud University, P.O.Box 2457, Riyadh 11451, Forensic Chemistry Department, Naif Arab University for Security Science, Riyadh, Department of Pharmacology and Toxicology, College of Pharmacy, King Saud University, P.O.Box 2457, Riyadh 11451, Pharmaceutical Chemistry Department, Faculty of Pharmacy, The British University in Egypt, El-Sherouk City, Cairo



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