Optimization of the assay method for velepotriates in complex cardic drops

Standardization of herbal medicines is a crucial aspect of the pharmaceutical industry, ensuring quality control, efficacy, and safety of plant-based medicinal products. One of the challenges in the analysis of herbal medicines is the complexity of determining biologically active compounds in multicomponent plant formulations. This study presents an optimized spectrophotometric method for the quantitative determination of valepotriates, which can be used for the standardization of herbal medicines intended for the prevention and treatment of cardiovascular diseases. The method is based on the ability of valepotriates to degrade in an acidic medium, forming colored compounds with a maximum absorption at 595 nm. To ensure reproducibility and accuracy, we investigated the effect of various organic solvents on the extraction efficiency of valepotriates. The solvents studied included chloroform, n-hexane, methylene chloride, and petroleum ether. It was found that the use of petroleum ether minimizes the interference of accompanying components and provides the best analytical characteristics for the method. The validation of the method confirmed its specificity, linearity (r = 0.9998), accuracy, and precision (ΔZ = 1.9%). The average content of valepotriates in the samples was determined to be 15.34 ± 0.34%. To verify the effectiveness of the method, a comparative analysis was conducted using high-performance liquid chromatography (HPLC). The results demonstrated a strong correlation between the methods, indicating no statistically significant differences (15.46 ± 0.34%, p > 0.05). Compared to HPLC, the spectrophotometric method is simpler, does not require expensive equipment, and can be implemented in pharmaceutical laboratories for routine quality control of herbal medicines. The high sensitivity and selectivity of the method allow for the analysis of complex multicomponent mixtures without the need for preliminary separation of components. The proposed approach is promising for ensuring the quality control of plant-based medicinal products and contributes to improving their efficacy and safety.