Abstract

SIMPLE AND SENSITIVE RP-HPLC METHOD FOR THE DETERMINATION OF METAXALONE IN BULK AND ITS PHARMACEUTICAL FORMULATION

Iffath Rizwana, Dr. K. VanithaPrakash*, Dr. G. Krishna Mohan

ABSTRACT

A simple, highly sensitive, precise and accurate high-performance liquid chromatographic method with Diode Array detection (DAD) was developed and validated for the rapid quantification of Metaxalone (CAS Registry No, 1665-48-1) in bulk and its pharmaceutical dosage form. The chromatographic separation was achieved with a reverse phase column Symmetry C8 (4.6 x 150mm, 3.5 m, Make: XTerra) and the mobile phase consisted of Acetonitrile: Potassium di hydrogen phosphate Buffer pH 7 adjusted with NaOH in the ratio of 65:35 v/v, at a flow rate of 0.6 mL/min, the injection volume was 20 μl with run time of 7 mins and UV detection was carried out at 219nm.The method was validated for specificity, linearity, precision, accuracy, robustness and system suitability. The method was linear in the drug concentration range of 20–60 μg/ml. The precision (RSD) of six samples was 0.22% for repeatability, and the intermediate precision (RSD) among six-sample preparation was 0.11%. The mean recovery was 99.4%. The proposed method can be used successfully for routine analysis of the drug in bulk and pharmaceutical dosage forms.

Keywords: Metaxalone, Diode Array detection, Acetonitrile, Potassium di hydrogen phosphate Buffer pH7.