Method development and validation for rapid identification of epigallocatechin gallate using ultra-high performance liquid chromatography.

Although Epigallocatechin gallate (EGCG) is the most available and beneficial catechin found in tea, its auto-oxidation property may lead to toxicity when consumed in large quantities. Thus, there is a need to quantify the EGCG, which enables to study the pharmacological characteristics of the compound. The study aimed to develop and validate a rapid and accurate analytical method for quantitative determination of EGCG. Standard EGCG was used to conduct trials for the optimization of the analytical method using Ultra-High Performance Liquid Chromatography (UHPLC). Tests for validation (specificity, linearity, accuracy, system suitability, method precision, robustness, and ruggedness) were performed. The preliminary trials yielded an analytical method with good peak shape and acceptable system suitability which was further validated. The method was shown to be specific, with a linear correlation coefficient of > 0.9996 and accurate with acceptable recovery rate (99.1% to 100.4%). Acceptable system suitability and method precision were confirmed with a relative standard deviation (less than 2%). Further, robustness and ruggedness experiments also demonstrated the suitability of the present analytical method. The method developed for determination of EGCG was validated as per the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and thus can be used in routine compliance tests in the laboratory for further studying/characterizing the properties of EGCG.