Design and content determination of nimesulide injectable formulation

The aim of the present study was to formulate Nimesulide inject able solution, establish a method for content determination, and accumulate data for registration of a new Nimesulide formulation. The optimal Nimesulide inject able formulation was determined based on the results of single factor test and orthogonal test. Moreover, clarity, stability, pH, content and related substances of Nimesulide were used as the main study indicators. The content of Nimesulide in inject able solution was determined by the high performance liquid chromatography (HPLC) method. The mobile phase consisted of V (methanol): V (potassium dihydrogen phosphate, pH 4.2)=60:40 at a flow rate of 1.0 mL/min. The detection was carried out with UV detector (λ(max) =254 nm) under a column temperature of 25°C and an injection volume of 20μL. The optimal inject able formulation was 4% Nimesulide, 4% ethanolamine, 0.1% L-cysteine, 0.01% EDTA-2Na, a suitable amount of lactic acid and water for injection. Nimesulide detection limits range from 20 to 80 μg/mL with a correlation coefficient of 0.9995 and high average recovery 99.91% (RSD=0.06%). In conclusion, the formulation was suitable for Nimesulide inject able form, and the determination method was simple, sensitive and accurate. Therefore, the Nimesulide inject able formulation can be used for industrial production and effectively controlled.