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

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.