title: Quantification of potential impurities by a stability indicating UV-HPLC method in niacinamide active pharmaceutical ingredient.
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.
authors: Analytical Research Department R&D Centre, Jubilant Life Sciences Ltd., Noida, Uttar Pradesh 201301, India. saji_thomas@jubl.com
authors: Saji
authors: S
authors: Thomas
authors: Amber
authors: A
authors: Bharti
authors: Kalsang
authors: K
authors: Tharpa
authors: Ashutosh
authors: A
authors: Agarwal
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods* / Q000706:statistics & numerical data; D056148:Chromatography, Reverse-Phase / Q000379:methods* / Q000706:statistics & numerical data; D004340:Drug Contamination / Q000706:statistics & numerical data*; D004355:Drug Stability; D057230:Limit of Detection; D009536:Niacinamide / Q000031:analogs & derivatives* / Q000032:analysis* / Q000737:chemistry; D010084:Oxidation-Reduction
chemical_list: D009536:Niacinamide