Studies For Method Development For Analysis Case Studies To Demonstrate The Accuracy Of Results At Micro Level

Abstract

newline SYNOPSIS newlineSTUDIES FOR METHOD DEVELOPMENT FOR ANALYSIS: CASE newlineSTUDIES TO DEMONSTRATE THE ACCURACY OF RESULTS AT MICRO newlineLEVEL newlineIntroduction newlineMethod development is required for both: a) analysis of bulk properties of the newlineanalytes present at macro levels (macro analysis) and b) analysis of constituents newlineincluding impurities present at micro level or residual level (micro analysis). For food newlinesafety which has become synonymous with food quality, microanalysis is a must. newlineMicroanalysis should be, therefore, carried out for two main purposes: newlinea. Qualitative and quantitative estimation of the presence of ingredients such as newlinemicronutrients, functional biochemicals, performance enhancing substances etc., newlineespecially in the case of functional foods, nutraceuticals and active newlinepharmaceutical ingredients. newlineb. Qualitative and quantitative estimation of ingredients that are not desired or newlineshould not be present in foods, functional foods, nutraceuticals and active newlinepharmaceutical ingredients. For example, certain solvent impurities in drugs and newlinepharmaceutical preparations, residues of pesticides, antibiotics, heavy metals newlineetc. in food and farm products, degradable substances in health care and food newlineproducts, leachables from the packaging materials into the contents of packaged newlinefoods etc. newlineThe results of microanalysis must be accurate and reliable. For this, the developed newlinemethod for any given analyte must be validated, as well. Hence, the method newlinedevelopment is useful only when the same is validated as per global standards. newlineMethod Development newlineIt is an established fact that when one evaluates the bulk properties like physical and newlinechemical characteristics e.g., purity of the sample or when the content of analyte is of newlinemacro level, the interferences due to matrix or due to presence of the other associated newlineingredients are insignificant. However, as the amount of the analyte decreases newlineconsiderably, relative to the bulk, the interferences start becoming prominent. Micro newlineanalysis is therefore, a complex process which involves extensive