Development of Validated Chromatographic Method for Simultaneous Estimation Taxifolin and Bergapten in Marketed Formulation

Abstract

Background: The biomarkers bergapten (BER) and taxifolin (TXN) have a variety of therapeutic effects, including anti-oxidant, anti-inflammatory, anti-microbial, and other pharmacological functions. The estimation of Taxifolin (TXN) and Bergapten (BER) as biomarkers in commercial formulations is demonstrated using new, straightforward, precise, and accurate HPTLC and UV methodologies.  Aim: The study establishes simultaneous estimation in addition to developing and validating method parameters in HPLC.  Objective: Application of the approach that has been developed to measure these biomarkers in industrial formulation. Materials and methods: The analytical grade chemicals and reagents were bought from Merck in India. The biomarkers utilized were (+)-taxifolin (95.0%) and bergapten (98.0% w/w) from Tokyo Chemical Industry Co., Ltd. The biomarkers were simultaneously estimated on method development parameters utilizing methods that used simultaneous estimation HPLC. Results: The biomarkers were separated using Agilent Technologies 1120 Compact LC with Cosmosil Packed column 5C18-MS-II, C 18 column, and optimized mobile phase of Acetonitrile (A) and Water (B) with 1% formic acid at wavelength of 299 nm. The biomarkers were verified using gradient. The gradient's flow rate was set at 60:40, 65:35, 70:30, and 75:25 from point A to point B. With Rt values of 4.853 and 15.390, respectively, Taxifolin and Bergapten were successfully resolved in compliance with ICH recommendations. The %RSD was not exceeded more than 2%. Conclusion: The specificity, linearity, precision, and accuracy of the newly developed HPLC technology have all increased. As part of a commercial formulation, the quantity and quality of biomarkers including a flavonoid and furanocoumarins were being validated.