HPLC Analysis of Antipsychotic Asenapine in Alternative Biomatrices: Hair and Nail Clippings

Abstract

Asenapine is a novel atypical antipsychotic drug for the treatment of schizophrenia and acute mania. Although some analytical methods have been published on the determination of the drug in conventional biological samples, such as blood serum and urine, there is currently no method available for alternative biomatrices, such as hair and nail clippings, which are of utmost importance in forensic and clinical toxicology. A reversed-phase analytical column, Inertsil C₈, (250 × 4.0 mm) 5 µm (MZ AnalysenTechnik, Mainz, Germany), was used at ambient temperature, with a mobile phase consisting of an acetate buffer (at pH 4.5), acetonitrile and methanol, (50:40:10%, v/v). Separation was achieved isocratically at a flow rate of 1 mL/min. Quantification was performed at 240 nm. Validation of the method was performed in terms of accuracy and precision: intra-day (n = 5) and inter-day (n = 3 × 5). Recovery rates ranged between 95.0% and 102.5% in hair samples and between 98.8% and 105% in nail samples. In hair the limit of detection was 1.3 ng/mg and the limit of quantitation was 4 ng/mg, whereas in nail clippings the respective values were 2.7 ng/mg and 8 ng/mg. The method was successfully applied to hair and nail clippings, following simple sample pretreatment.

Keywords:

• Asenapine
• bioanalysis
• forensic toxicology
• hair
• HPLC
• nail clippings

Acknowledgments

The authors wish to thank Merck Sharp & Dohme Corp. (Rahway, NJ, USA) and H. Lundbeck A/S (Denmark) for the kind donation of asenapine.