Kinetics study of metaxalone degradation under hydrolytic, oxidative and thermal stress conditions using stability-indicating HPLC method

An isocratic stability indicating RP-HPLCâUV method is presented for the determination of metaxalone (MET) in the presence of its degradation products. The method uses Dr. Maisch C18 column (250 mmÃ4.6 mm, 5 μm) with mobile phase consisting of acetonitrileâpotassium dihydrogen orthophosphate buf...

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Bibliographic Details
Main Authors: Vamsi Krishna Marothu, Rajendra N. Dash, Saritha Vemula, Shravani Donkena, Ramesh Devi, Madhavi Gorrepati
Format: Article
Language:English
Published: Elsevier 2012-12-01
Series:Journal of Pharmaceutical Analysis
Online Access:http://www.sciencedirect.com/science/article/pii/S2095177912001074
Description
Summary:An isocratic stability indicating RP-HPLCâUV method is presented for the determination of metaxalone (MET) in the presence of its degradation products. The method uses Dr. Maisch C18 column (250 mmÃ4.6 mm, 5 μm) with mobile phase consisting of acetonitrileâpotassium dihydrogen orthophosphate buffer with 4 mL of 0.4% triethyl amine (pH 3.0; 10 mM) (58:42, v/v) at a flow rate of 1.0 mL/min. pH of the buffer was adjusted with o-phosphoric acid. UV detection was performed at 225 nm. The method was validated for specificity, linearity, precision, accuracy, limit of detection, limit of quantification and robustness. The calibration plot was linear over the concentration range of 1â100 μg/mL having a correlation coefficient (r2) of 0.999. Limits of detection and quantification were 0.3 and 1 μg/mL, respectively. Intra-day and inter-day precision (% RSD) was 0.65 and 0.79 respectively. The proposed method was used to investigate the degradation kinetics of MET under different stress conditions employed. Degradation of MET followed a pseudo-first-order kinetics, and rate constant (K), time left for 50% potency (t1/2), and time left for 90% potency (t90) were calculated. Keywords: Metaxalone, Degradation kinetics, RP-HPLCâUV
ISSN:2095-1779