Preclinical pharmacokinetics and biodistribution studies of asenapine maleate using novel and sensitive RP–HPLC method

Author:

Managuli Renuka S1,Gourishetti Karthik2,Shenoy Rekha R2,Koteshwara Kunnatur B1,Reddy Meka Sreenivasa1,Mutalik Srinivas1

Affiliation:

1. Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal 576104, Karnataka State, India

2. Department of Pharmacology, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal 576104, Karnataka State, India

Abstract

Aim: Asenapine maleate (ASPM) is a newer antipsychotic drug available as a sublingual tablet in the market. Experimental: To investigate the pharmacokinetic and tissue distribution study of ASPM following oral administration in rats, reversed-phase HPLC method was developed and validated. Results: ASPM was extracted from plasma and tissue matrix by liquid–liquid extraction technique and analyzed using mobile phase consisted of phosphate buffer pH 3.0 and acetonitrile (65:35% v/v). The method showed good linearity (10–500 ng/ml) with recovery 83–102%. In pharmacokinetics study, half-life was 32.74 ± 7.51 h due to slow elimination of drug. The biodistribution study indicated preferential distribution of ASPM to highly perfused organs. Conclusion: The current method can be successfully applied for estimating the drug in various biological matrices.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Reference17 articles.

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2. Chiral separation of asenapine enantiomers by capillary electrophoresis and characterization of cyclodextrin complexes by NMR spectroscopy, mass spectrometry and molecular modeling

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4. Asenapine (Saphris(R)): GC-MS Method Validation and the Postmortem Distribution of a New Atypical Antipsychotic Medication

5. Fast quantification of ten psychotropic drugs and metabolites in human plasma by ultra-high performance liquid chromatography tandem mass spectrometry for therapeutic drug monitoring

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