Determination of Pterostilbene in Pharmaceutical Products Using a New HPLC Method and Its Application to Solubility and Stability Samples

The quantification of a natural bioactive compound, pterostilbene (PTT), in commercial capsule dosage form, solubility, and stability samples was carried out using a rapid and sensitive high-performance liquid chromatography (HPLC) approach. PTT was quantified on a Nucleodur (150 mm x 4.6 mm) RP C-18 column with a particle size of 5 mu m. Acetonitrile and water (90:10 v/v) made up the mobile phase, which was pumped at a flow speed of 1.0 mL/min. At a wavelength of 254 nm, PTT was detected. The developed HPLC approach was linear in 1-75 mu g/g range, with a determination coefficient of 0.9995. The developed HPLC approach for PTT estimation was also rapid (R-t = 2.54 min), accurate (%recoveries = 98.10-101.93), precise (%CV = 0.59-1.25), and sensitive (LOD = 2.65 ng/g and LOQ = 7.95 ng/g). The applicability of developed HPLC approach was revealed by determining PTT in commercial capsule dosage form, solubility, and stability samples. The % assay of PTT in marketed capsules was determined to be 99.31%. The solubility of PTT in five different green solvents, including water, propylene glycol, ethanol, polyethylene glycol-400, and Carbitol was found to be 0.0180 mg/g, 1127 mg/g, 710.0 mg/g, 340.0 mg/g, and 571.0 mg/g, respectively. In addition, the precision and accuracy of stability samples were within the acceptable limit, hence PTT was found to be stable in solution. These results suggested that PTT in commercial products, solubility, and stability samples may be routinely determined using the established HPLC method.

Automated summary

A rapid and sensitive HPLC method was used to quantify pterostilbene (PTT) in commercial capsule dosage form, solubility, and stability samples. The HPLC method utilized an RP C-18 column and a mobile phase of acetonitrile and water. PTT was detected at a wavelength of 254 nm. The HPLC method was found to be linear, accurate, precise, and sensitive, with a high determination coefficient. The method was successfully applied to determine PTT in commercial products, solubility, and stability samples.