Abstract
Abstract A rapid and sensitive method for the assay of neostigmine methylsulfate (NMS) in injectables has been developed. Following extraction of phenol and paraben preservatives, NMS is hydrolyzed to 3-dimethylaminophenol, which is determined by ultraviolet spectrophotometry. Standard recoveries of NMS from simulated injection solutions containing either (1) no preservatives, (2) phenol, or (3) parabens averaged 99.8%. A collaborative study was conducted using 2 simulated injection solutions (one without preservatives, one containing parabens) and 2 commercial injectables (one containing phenol, one containing parabens). Results of 9 collaborators averaged 100.6±1.4 and 102.1±1.5% for the simulated solutions. Results for the 2 commercial preparations averaged 103.0±1.2 and 101.8±1.6% of the respective label declarations. The results of the proposed method are in good agreement with the USP XVII and the new USP XVIII methods. The method is recommended for adoption as official first action.
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