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

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.

► First report on quantitative determination of potential impurities of niacinamide.
► The newly developed HPLC method was found to give excellent resolution for six impurities.
► Efficient chromatographic separation was achieved on a C18 stationary phase in simple isocratic mode.
► Forced degradation study confirmed the stability indicating nature of the method.
► Major oxidative degradant was identified as niacinamide N-oxide.