DEVELOPMENT AND VALIDATION OF DERIVATIVE UV SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF DULOXETINE

Development and validation of a simple UV spectroscopic method for the determination of Duloxetine by the derivative spectro-photometric method is the objective of the present work. The analysis was carried out by using Shimadzu UV-1700, and Shimadzu UV-1800 UV spectrophotometer, and Acetonitrile and water (8:2) was used as solvent or mobile phase. Detection or qualitative analysis was carried out at a wavelength of 240 nm. ICH guidelines were followed to verify the method validation process by using various parameters like linearity, accuracy, precision (interday and intraday), ruggedness, robustness, the limit of detection (LOD), and limit of quantification (LOQ). According to Beer’s Lambert’s law, the derivative UV spectrophotometric method was found linear in the range of 10-50 μg/ml. The analytical method was rugged and robust with a % relative standard deviation of less than 1.8. The percentage recoveries were higher than 98.7% in all the validation parameters and conditions. Based upon the analytical experiment, the developed method was found accurate, precise and rapid, and suitable for the rapid determination of Duloxetine for routine analysis.