DEVELOPMENT AND VALIDATION OF UV SPETROSCOPIC METHOD FOR ESTIMATION OF METAXALONE IN BULK AND MICROEMULSION AT DIFFERENT PHYSIOLOGICAL PH
Nitesh Waman1*, Rohit Ajage1, Prakash Kendre1, Veena Kasture1
1Department of Quality Assurance Techniques, Sanjivani College of Pharmaceutical Education and Research, Kopargaon, Maharashtra
Abstract
Metaxalone, a muscle relaxant and pain reliever caused due to strain, sprains. It is considered as a strong muscle relaxant and with relatively low side effects. The UV spectroscopic method is simple, precise, accurate, rugged, robust and economic for estimation of the drug in microemulsion form. The present study explores a method to analyze Metaxalone in different solvents like 0.1N HCl (gastric fluid), phosphate buffer (pH 6.8) and phosphate buffer saline (pH 7.4) as per ICH guidelines. The objective of the study was to determine the effect of different pH on absorbance and to develop validated method for estimation of Metaxalone in different simulated body fluids since it is oral dosage form. The spectrophotometric analysis was done at λmax 270.8 nm. Calibration curve showed a linear relationship between the absorbance and concentration. The Beer’s law was obeyed in the concentration range 30-180 μg/ml for different simulated body fluids. The method was validated as per ICH guidelines, the SD and %RSD for metaxalone in 0.1N HCl, Phosphate buffer pH 6.8 and phosphate buffer pH 7.4 was 0.00339 and 0.729, 0.00254 and 0.573, 0.00304 and 0.66 respectively. The simple sensitive and cost effective UV Spectrophotometric method was developed for estimation of metaxalone at different pH. The method is also applicable for bioavailability studies.