ABSTRACT:
A simple, precise, accurate and economical UV spectrophotometric methods have been developed and validated for the estimation of Duloxetine hydrochloride in tablet dosage form. Standard stock solution was prepared in water. The resulting solutions were then scanned in the UV range (200-400nm) in a double beam UV Visible spectrophotometer. The drug shows maximum absorption at 218nm. In these methods the drug obeyed Beer-Lambert’s law in the concentration range of 5.0-30 microgram/ml. The linear regression equations were calculated to be y = 0.100x+0.039, R=0.999. The results of estimation of marketed tablet formulations were found to be 99.1±0.001 with their %RSD less than 2. Recovery studies were carried out by addition of known amount of standard drug to the powdered tablet. The % recovery was found to be 99.16±0.44, which indicates accuracy and reliability of the validated methods as well as non-interference from excipients to the developed methods. The intraday and interday assay was within 2%. The method was then validated statistically as per the ICH guidelines which yielded good results concerning range, precision, accuracy, specificity, robustness and ruggedness.