Abstract
The purpose of this study is to check the effectiveness of the analysis method that separates and quantifies β-caryophyllene among clove extracts and validate according to current ICH guidelines. The β-caryophyllene was active constituent of clove buds. The developed method gave a good detection response. In the specificity test, the standard solution was detected at about 17.32 min, and the test solution was detected at 17.32 min. The linearity of β-caryophyllen was confirmed, and at this time, the correlation coefficient (R2) of the calibration curve showed a high linearity of 0.999 or more in the concentration range. The levels of LOD and LOQ were 1.28 ug/mL and 3.89 ug/mL, respectively. The accuracy was confirmed to be 101.6–102.2% and RSD 0.95 ~ 1.31%. As a result of checking the repeatability and inter-tester reproducibility to confirm the precision, the RSD was found to be 1.34 ~ 2.69%. This validated GC method was successfully applied to a soft capsule containing clove extract and other materials for clinical trials. Therefore, this method can be used as an analytical tool for quality control of various samples, including clove extracts and their products of food and pharmaceutical uses.
Highlights
The purpose of this study is to check the effectiveness of the analysis method that separates and quantifies β-caryophyllene among clove extracts and validate according to current ICH guidelines
We developed and validated analytical method of the estimation of β- caryophyllene in clove extracts to applicates for functional materials according to ICH guidelines
The US Food and Drug Administration (FDA) categorizes clove oil or its components as generally recognized as safe (GRAS) for the purpose of dental cement use or food additive use[17]
Summary
The purpose of this study is to check the effectiveness of the analysis method that separates and quantifies β-caryophyllene among clove extracts and validate according to current ICH guidelines. As a result of checking the repeatability and inter-tester reproducibility to confirm the precision, the RSD was found to be 1.34 ~ 2.69% This validated GC method was successfully applied to a soft capsule containing clove extract and other materials for clinical trials. Regarding development of therapeutic or functional agents of plans, a validated analytical method is required at every step Among other things, it is necessary at the step of the quantification of the active compounds in biological components for tracking preclinical and clinical analysis[4]. We developed and validated analytical method of the estimation of β- caryophyllene in clove extracts to applicates for functional materials according to ICH guidelines. The application of the developed method of commercial formulations containing clove extract will be very satisfactory
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