Quantitative Chemical Profiling of Commercial Glyceride Excipients via(1)H NMR Spectroscopy

Glycerides are the main components of oils, and fats, used in formulated products in the food and cosmetic industry as well as in the pharmaceutical product industry. However, there is limited literature available on the analysis of the chemical composition of glycerides. The lack of a suitable analytical method for complete chemical profiling of glycerides is one of the bottlenecks in understanding and controlling the change in chemical composition during processing, formulation, and storage. Thus, the aim of the present study is to develop a calibration-free quantitative proton nuclear magnetic resonance (qHNMR) method for the simultaneous quantification of different components of glycerides. The qHNMR method was developed for the quantification of mono-, di-, and triglycerides; their positional isomers; free fatty acids; and glycerol content. The accuracy, precision, and robustness of the developed method were evaluated and were found suitable for the quantitative analysis of five batches of marketed excipient. The study demonstrates the potential of qHNMR method for the quantification of different components of glycerides in various marketed products. The method has the ability to identify the variability of glycerides among different batches and suppliers in terms of chemical composition and also to discern the changes during storage. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1208/s12249-020-01883-x.