Development and Validation of UV-Visible spectroscopic method for estimation of Nimesulide in bulk and its pharmaceutical formulation

Abstract

The aim of the present work was to develop and validate a simple UV Spectroscopic method for the determination of Nimesulide, which is the inhibitor of prostaglandin synthesis from arachidonic acid and platelet aggregation. It has the ability to exert analgesic and anti-inflammatory actions through various mechanisms (ie, COX independent pathways) and also it inhibits the release of tumour necrosis factor (TNFα) and interleukins, and stops the release of histamine from mast cells and reduce the synthesis of platelet activating factor (PAF) from the basophil cells. The UV visible Spectrophotometric analysis was performed using systronics UV-Spectrophotometer 2704 X visible double beam by using solvent KOH. Detection was performed at a wavelength of 395nm. Method validation was carried out according to ICH Q2R1 guidelines by taking the parameters such as accuracy, linearity, precision, ruggedness, and robustness, LOD and LOQ. The UV spectrophotometric was found linear in the range 5- 25µg/ml. The method was rugged and robust with % relative standard deviation less than 2. The extraction recoveries was found to be higher than 99.19% in all experimental conditions. Based upon the performance characteristics, the proposed method was found accurate, precise, rapid and suitable for the determination of nimesulide for routine analysis. The aim of the present work was to develop and validate a simple UV Spectroscopic method for the determination of Nimesulide, which is the inhibitor of prostaglandin synthesis from arachidonic acid and platelet aggregation. It has the ability to exert analgesic and anti-inflammatory actions through various mechanisms (ie, COX independent pathways) and also it inhibits the release of tumour necrosis factor (TNFα) and interleukins, and stops the release of histamine from mast cells and reduce the synthesis of platelet activating factor (PAF) from the basophil cells. The UV visible Spectrophotometric analysis was performed using systronics UV-Spectrophotometer 2704 X visible double beam by using solvent KOH. Detection was performed at a wavelength of 395nm. Method validation was carried out according to ICH Q2R1 guidelines by taking the parameters such as accuracy, linearity, precision, ruggedness, and robustness, LOD and LOQ. The UV spectrophotometric was found linear in the range 5- 25µg/ml. The method was rugged and robust with % relative standard deviation less than 2. The extraction recoveries was found to be higher than 99.19% in all experimental conditions. Based upon the performance characteristics, the proposed method was found accurate, precise, rapid and suitable for the determination of nimesulide for routine analysis.