DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF AGOMELATINE IN NANOSTRUCTURED LIPID CARRIERS

摘要

The objective of work was to develop and validate a UV spectrophotometric method for determination of agomelatine (AGM) loaded in nanostructured lipid carriers (NLCs). The solvent and wavelength of detection were optimized in order to maximize sensitivity of proposed method. The method was validated for different parameters like linearity, precision, specificity, accuracy, limit of detection (LOD), limit of quantitation (LOQ) and robustness as per ICH guidelines. A wavelength maximum of AGM in methanol: chloroform (7:3V/V) mixture was found at 235nm. The method was found to be linear in the range of 1 to 6 mug/mL with a correlation coefficient (r2) of 0.997. The accuracy of the method was studied by recovery study and % recovery was found in range of 99 to 100.11 %. The LOD and LOQ were found to be 0.043 mug/mL and 0.141 mug/mL respectively. The method is simple, accurate and requires relatively inexpensive instrument. The method was used successfully for determination of AGM loaded into NLCs.