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Quantification of potential impurities by a stability indicating UV-HPLC method in niacinamide active pharmaceutical ingredient

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Abstract

A sensitive, stability indicating reverse phase UV-HPLC method has been developed for the quantitative determination of potential impurities of niacinamide active pharmaceutical ingredient. Efficient chromatographic separation was achieved on C18 stationary phase in isocratic mode using simple mobile phase. Forced degradation study confirmed that the newly developed method was specific and selective to the degradation products. Major degradation of the drug substance was found to occur under oxidative stress conditions to form niacinamide N-oxide. The method was validated according to ICH guidelines with respect to specificity, precision, linearity and accuracy. Regression analysis showed correlation coefficient value greater than 0.999 for niacinamide and its six impurities. Detection limit of impurities was in the range of 0.003-0.005% indicating the high sensitivity of the newly developed method. Accuracy of the method was established based on the recovery obtained between 93.3% and 113.3% for all impurities.

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... Niacinamide (NIA), chemically known as pyridine-3-carboxamide, is an amide form of vitamin B3 and a water-soluble molecule with a wide range of mechanisms of action that have been described in the literature [6,7]. This vitamin is not naturally stored in the body, but it can be obtained by the dietary intake of vitamin B3 and tryptophan [8]. ...
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