Development, optimization and validation of a fingerprint of Ginkgo biloba extracts by high-performance liquid chromatography.
A four-step development, optimization and validation strategy for high-performance liquid chromatography (HPLC) fingerprints of Ginkgo biloba extract is described. A suitable chromatographic system was selected first. The following step was performing a screening design to select important parameters. After selecting some controllable parameters and their range to further optimize, gradient optimization with uniform design was done. At last, method validation including determination of injection precision, repeatability, and a sample stability test, was performed. Through this effective and integrated four-step method, a feasible and reliable HPLC fingerprint to identify and assess the Ginkgo biloba quality can easily be established using a linear gradient elution with acetonitrile/0.1% phosphoric acid (from 14/86 to 30/70, v/v, in 40 min) as mobile phase, a column temperature of 30 degrees C and a detection wavelength of 350 nm. The strategy can also be applied for the development of fingerprints in the quality control of other herbal medicines.