Xây dựng và thẩm định phương pháp định lượng Epicatechin trong viên nang cứng chứa cao khô hạt vải bằng sắc ký lỏng hiệu năng cao

Abstract

Objective: To develop and validate a high-performance liquid chromatography (HPLC) method for the quantification of epicatechin in hard capsules containing Litchi chinensis seed dry extract.

Subjects and methods: The study subject was hard capsules containing litchi seed dry extract. A high-performance liquid chromatography method coupled with UV detector (HPLC-UV) was used for the quantification of epicatechin. The chromatographic conditions included a C18 column (250 × 4.6 mm; 5 µm), a mobile phase consisting of acetonitrile and 0.085% phosphoric acid solution with gradient elution, a flow rate of 1.0 ml/min, an injection volume of 10 µL, and a detection wavelength of 202 nm. The method was validated according to the following criteria: specificity, system suitability, precision, linearity, and accuracy.

Results: The developed HPLC-UV method showed good specificity. The epicatechin peak in the sample solution appeared at a retention time of approximately 12 minutes and was not interfered with by other components in the sample matrix. The linearity range of the method was 1.5–30 µg/ml with a correlation coefficient R² = 0.9999. System suitability and precision met the acceptance criteria with RSD < 2%. LOD = 0.5 µg/mL, LOQ = 1.5 µg/ml. Accuracy was evaluated by the standard addition method at three concentration levels (50%, 100%, and 150%), yielding recovery rates within the acceptable range.

Conclusion: An HPLC-UV method has been successfully developed and validated for the quantification of epicatechin in hard capsules containing litchi seed dry extract. The method is highly reliable and can be applied for the quality control and quality assurance of preparations containing litchi seed dry extract.