Abstract
The project, for the first time, reports the development of sustained release granules of Diclofenac sodium and Eperisone hydrochloride. The granules were subjected to physical tests, dissolution profiling as well as assay. The analytical method was developed for both the drugs as API and for sustained release granules on Shimadzu UV-1800 spectrophotometer by simultaneous equation method. Phosphate buffer of pH 6.8 was selected as a common solvent for estimation of Diclofenac and Eperisone at 276 nm and 261.4 nm respectively. Beer law was obeyed in the range of 2-22 mg/ml and 2.5-32.5 mg/ml with correlation coefficient of 0.999 and 0.998 respectively. Detection limit and quantification limit were found to be 0.082 mg/ml and 0.22 mg/ml for Eperisone and 0.109 mg/ml and 0.331mg/ml for Diclofenac respectively. Developed method was found to be simple, accurate, precise, reproducible and in agreement with all the validation criteria as per ICH with negligible interference from excipients. Assay results were found to be 98.76% and 100.09% for Eperisone HCl and Diclofenac Na respectively. The sustained release granules passed all the physical tests and demonstrated good dissolution profile.
