Abstract

BIOANALYTICAL AND ANALYTICAL METHOD DEVELOPMENT, VALIDATION APPROACHES FOR METAXALONE: A BRIEF REVIEW

Dilip B. Yamgar*, Mayur N. Desale, Malesh S. Prajapati, Bharti Fegade and Bhaskar Vaidhun

ABSTRACT

Metaxalone (MTX), a non-benzodiazepine antispasmodics, resembling in structure to mephenaxalone is a BCS Class II drug that acts centrally to skeletal muscle relaxant drug with antispasmodic effect. Although the exact mode of action of MTX is not fully understood, it has been stated that it acts via the general CNS depression method resulting in relaxation of skeletal muscles and also sedation. It has been formulated under the brand name of SKELAXIN and distributed by King Pharmaceuticals. The dosage form available in the market for the drug contains 400 and 800 mg of drug with excipients. The bioavailability of Metaxalone has been found to increase when taken on a full stomach. After intake of MTX in any form strictly avoid excessive or chronic consumption of alcohol. This often leads to an increase in CNS depressant effects. Literature survey has demonstrated that fewer methods are available to perform the characterization of Metaxalone in bulk solution as well as biological fluids. Some of the methods are electrospray ionization (ESI), LC-MS/MS, UV spectroscopy combined with LC chromatography, HPLC-UV, GC with flame ionization detector, GC with MS. The present review comprehensively overlooks the all of above methods for estimation of Metaxalone in its bulk solution as well formulation and in biological fluids.

Keywords: Analytical method, Bioanalytical method, Metaxalone, validation.