ABSTRACT:
Objectives: The present study aims to formulate and evaluate a parenteral nutritional formulation that is used to combat malnutrition. The product was also assessed for the specific limit, to maintain the quality of the product so that the product is safe for the human consumption. Methods: The current study mainly focuses on analysis of concentration of Sodium (Na), Potassium (K), Magnesium (Mg) and Calcium (Ca) in amino acid compartment of nutritional formulation with the help of Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES). In this system, the solution was first nebulized and then heated at high temperature in plasma where it was decomposed into excited atoms and ions. These excited atoms and ions of each element emit a characteristic electromagnetic radiation in UV and visible wavelength. The intensity of this radiation at a chosen wavelength was proportional to the concentration of the elements in the solution. Thus Na, Ca, K and Mg present in amino acid compartment were quantified by comparison with calibration curves obtained from working standards. Results: As per ICH-Q2 R1 guidelines, the results of various validation parameters such as linearity, accuracy and specificity of the system were analyzed. The regression co-efficient value for linearity was found to be 0.9995, the accuracy and specificity were found to be in the range of 98-102%, respectively. Conclusion: The results concluded that the formulated nutritional formulation passed all the system suitability criteria and there by the product could be used to combat malnutrition.