As an important raw material for medicine and health products, the batch consistency of Eucommia extract is directly related to product quality and efficacy. In industrial production, high-performance liquid chromatography (HPLC) technology has become a key detection method to ensure product batch consistency due to its high precision and high sensitivity. Among them, the relative standard deviation (RSD) is an important indicator to measure the degree of data dispersion, and it is required to be controlled within 1% to meet strict quality control standards.
To understand the core of this technology, we first need to clarify what HPLC and RSD stand for. HPLC is an analytical method that uses high pressure to drive the mobile phase to achieve efficient separation of samples in the chromatographic column. RSD intuitively reflects the reproducibility of the test data by calculating the coefficient of variation of repeated measurement results. The smaller the RSD value, the more stable the test results and the smaller the difference between batches.
The first is to ensure that the sample pretreatment process is in compliance with standardization. From sampling, weighing to dissolution and filtration, each step needs to be strictly carried out in accordance with standard operating procedures. In particular, the preparation of sample solutions must ensure complete dissolution and moderate concentration to avoid detection fluctuations due to uneven samples.
Second, the key to ensuring reproducibility is to optimize chromatographic conditions. Parameters such as the optimal mobile phase ratio, column temperature and flow rate are determined through repeated experiments. For example, we found that when the column temperature is controlled at 30±0.5℃ and the mobile phase pH value deviation does not exceed 0.1 unit, the retention time difference of the target component can be controlled within 0.1 minute.
Third, the maintenance of the instrument status cannot be ignored. Regularly replace the chromatographic column guard column, perform pump seal maintenance on time, and establish a strict instrument calibration system. Our laboratory stipulates that system suitability tests must be performed for every 50 samples tested to ensure stable instrument performance.
Finally, in terms of data processing, we use the multi-point calibration curve method, requiring the correlation coefficient R²≥0.999. Each batch of samples is measured in parallel 6 times, and the average value is calculated after eliminating outliers. At the same time, quality control sample monitoring is introduced to ensure that the entire detection process is under control.
1. Establish strict quality standards when purchasing raw materials and implement hierarchical management of suppliers
2. Automated control of production process parameters, and control extraction temperature fluctuations within ±1℃
3. Establish a complete quality traceability system to ensure full monitoring from raw materials to finished products
● Sample solution is prepared and used immediately, and the storage time does not exceed 4 hours
● Intersperse standard products for intermediate calibration in each batch of testing
● Regularly compare personnel operations to ensure consistent testing methods
● Establish a complete electronic original record system
Through the above systematic measures, our laboratory has maintained the HPLC test RSD between 0.3-0.8% for three consecutive years, effectively ensuring the batch consistency of Eucommia extract products. This refined quality control model also provides experience for reference for the production and testing of other plant extracts.
