DEVELOPMENT AND VALIDATION OF Q-ABSORBANCE RATIO SPECTROPHOTO-METRIC METHOD FOR SIMULTANEOUS ESTIMATION OF MANGIFERIN AND BERBERIN HCl IN BULK AND SYNTHETIC MIXTURE

There are so many promising plant based chemical constituents are present which act as alternative therapy for the control of diabetes. But due to lack of its proper quality control parameters they are not widely used. The US FDA patent is approved for fixed dosage combination of Mangiferin (MF) and Berberin HCl (BER) as antidiabetic herbal formulation. Absorbance ratio method uses the ratio of absorbances at two selected wavelengths, one which is an iso-absorptive point and other being the lambda(max) of one of the two components. From the overlay spectra of two phytomarkers, it is evident that MF and BER show an iso-absorptive point at 317 nm. The second wavelength used is 257 nm, which is the lambda(max) of MF. The drug response with respect to absorbance was linear over the concentration range 5 - 30 mu g/ml for MF and 10 - 60 mu g/ml for BER. The percentage recovery of MF and BER as found to be 100.00% and 100.07% respectively. The method can be successfully employed for the simultaneous determination of MF and BER in pharmaceutical formulations. The developed method is validated as per ICH guideline Q2 (R1).