LC-MS/MS analytical method for the estimation and validation of nutraceutical: Niacin in human plasma

Over the last 20 years the number of nutraceuticals available for self medication in pharmacies or and health food shops has grown enormously. Nutraceuticals usually appear to be packed and labeled as if they were medicine. Analytical method development is the process of creating a procedure to enable a new chemical entity of potential therapeutic value to be quantified in a biological matrix. A sensitive, specific, accurate, and reproducible HPLC/MS-method for the quantitative determination of Nutraceutical: Niacin in human plasma using Nevirapine as an internal standard for the hyperlipidimia conditions was developed and validated according to USFDA guidelines. Analyte and the internal standard were separated by Liquid-Liquid extraction. In the present study LC MS/MS (API 3000) Method of extraction procedure is short and simple, it consumes small amount of solvent and biological fluid for extraction and short turnaround time when compared to earliest methods. The chromatographic separation was achieved within 3 min by an isocratic mobile phase containing 0.1% Formic acid in water and Acetonitrile (20:80 v/v), flowing through HYPERSIL BDS,150×4.6mm, 5.0μm analytical column, at a flow rate of 1.0mL mil-1 . The calibration curves were linear in the measured range between 100.1 and 20009.7 ng/mL plasma. No indications were found for possible instabilities of niacin in plasma at ？20 °C, in the extraction solvent or after repeated thawing/freezing cycles