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A kinetic spectrophotometric method based on the initial rate measurement has been developed for the determination of N-acetyl L-cysteine. The developed method is based on the oxidation of N-acetyl L-cysteine with iodate. The reaction product was studied and characterized using the mass spectrometry and the structure of the product was proposed. From the mass spectrometric studies it was concluded that the oxidation of the drug resulted in the formation of a disulfide. The developed method was validated as per the guidelines of international conference on harmonization. The developed initial rate method was found to be linear in the concentration range of 1.25 - 30 µg ml-1. The detection and quantitation limits were found to be 0.018 and 0.056 µg ml-1. In the current study, the degradation For the assessment of accuracy and precision, the quality control samples were prepared at three concentration levels of 1.25 µg ml -1 , 15 µg ml -1 and 30 µg ml -1 . The pharmaceutical dosage form Mucinac-600 was obtained from the lo- cal market. A 0.038 M KI and 0.007 M KIO 3 (BDH Chemicals limited Poole, England) solutions were freshly prepared. Proposed procedure for the determination of N-acetyl L-cysteine N-acetyl L-cysteine standard solution equivalent to 1.25 µg ml -1 - 30 µg ml -1 were pipetted into a series of 10 ml standard flask. To each standard flask 1.5 ml of 0.0072 M KIO 3 was added followed by addition of 1.8 ml of 0.026 M KI and made up to the mark with milli Q water. The content of the each standard flasks were thoroughly mixed and was subjected to spectrophoto - metric studies and increase in the absorbance was recorded at 352 nm. The absorbance-time plot was prepared and initial rate of the reaction (ν) at various concentrations was obtained by measuring the slope of the tangent of the previ- ously plotted absorbance-time curve. The analyses were performed at 30±1oC. Determination of N-acetyl L-cysteine in commercial dosage form Two tablets equivalent to 1200 mg of N-acetyl L-cysteine was weighed crushed and the amount of the crushed tablet equivalent to 250 mg of N-acetyl L-cysteine was dissolved in 1000 ml of milli Q water in a volumetric flask. The content of the flask was sonicated for 5 minutes and filtered. N-acetyl L- cysteine equivalent to 1.25 -30 µg ml -1 were pipetted and analyzed by the above mentioned procedure. The amount of the drug was calculated either from the calibration graph or from the linear regression equation. Optimization of variables During the experiments the optimum condition responsible for the forma- tion of the yellow colored products was studied and the same was maintained throughout the determination process. Effect of the concentration of KIO 3 The effect of potassium iodate on the initial rate of reaction was studied in the concentration range of 1.43 × 10 -4 M - 1.22 × 10

journal of the chilean chemical society

IODATE OXIDATION OF N-ACETYL L-CYSTEINE: APPLICATION IN DRUG DETERMINATION AND CHARACTERIZATION OF ITS OXIDATION AND DEGRADATION PRODUCT BY MASS SPECTROMETRY