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Development of RP-HPLC Method for Rapid Determination of Metaxalone and in Bulk and its Solid Oral Dosage form

S. Praveena, S. Muneer, B. Famida, P. Sathya Sowmya, B. Mohammed Ishaq and Hindustan Abdul Ahad

A simple, sensitive and reproducible reversed phase high performance liquid chromatography (RP-HPLC) coupled with a UV det ector method was developed for the quantitative determination of metaxalone (MET) in pharmaceutical dosage forms. Th e method is applicable to the quantif ication of related substances and assay of drug product. Chromatographic separation was achieved on a BDS Hypersil C-18 (150 mm x 4.6 mm, 5 μ m) column. The optimized isocratic mobile phase consists of a mixture of methanol: water, in the ratio of 90:10 % v/v. The eluted compounds were monitored at 279 nm for MET assay, the flow rate was 1 mL/min, and the column oven temperature was maintained at room temperature. The developed method separated MET from its excipients within 6.0 min. The developed method was validated as per International Conference on Harmonization (ICH) guidelines. The method was validated for specificity, linearity, precision, acc uracy, robustness and system suitability. The method was linear in the drug concentration range of 10-60 μ g/mL. The precision (% RSD) of six samples was 1.67. The mean recoveries were between 100.96%. The proposed method can be used successfully for routine analysis of the drug in bulk and combined pharmaceutical dosage forms.