DEVELOPMENT AND VALIDATION OF FIRST ORDER DERIVATIVE SPECTROSCOPIC METHOD FOR SIMULTANEOUS ESTIMATION OF MANGIFERIN AND BERBERIN HCL IN BULK AND SYNTHETIC MIXTUREAbstract
Introduction: There are so many promising plant-based chemical constituents are present which act as an alternative therapy for the control of diabetes. But due to the lack of its proper quality control parameters, they are not widely used. The USFDA patent is approved for a fixed dosage combination of Mangiferin (MF) and Berberin HCl (BER) as antidiabetic herbal formulation. Objective: The literature review suggested that no UV spectroscopic method been reported in the literature review for the combination formulation of MF and BER. Methodology: The method is based on a simultaneous method using two wavelengths, 257 nm (λmax of MF) and 265 nm (λmax of BER). Methanol was used as a solvent. Results: The drug response with respect to absorbance was linear over the concentration range 5-30 μg/ml for MF and 10-60 μg/ml for BER. The percentage recovery of MF and BER as found to be 100.00% and 99.48%, respectively. The % R. S. D. values for intra-day, and the inter-day precision study was less than 2.0%, confirming that the method was sufficiently precise. Conclusion: 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) for global acceptance of standardized herbal formulations.
B. Patel, H. Patel, M. Gohil and S. Parmar *
Department of Pharmaceutical Sciences, Sardar Patel University, Vallabh Vidyanagar, Gujarat, India.
18 November 2019
10 August 2020
04 September 2020
01 November 2020