IDENTIFICATION AND QUANTIFICATION OF BERBERINE IN A POLYHERBAL FORMULATION BY HPTLC METHOD

Diabetes mellitus is a challenging human disorder for medical researchers, and the patients suffering from it are from all age groups and countries. BSL-150 tablets is a polyherbal formulation used for the treatment of diabetes mellitus. It contains seeds of Syzygium cumini, bark of Tinospora cordifolia, leaves of Gymnema sylvestre and seeds of Phyllanthus emblica. These plants’ dried, powdered parts in the same quantities as marketed tablets were mixed to obtain the in-house formulation. The phytochemical analysis of the methanolic extracts of in-house and marketed samples showed presence of flavonoids, steroids, alkaloids, terpenoids, phenols, saponins and tannins. Berberine, an isoquinoline alkaloid, was identified in samples using HPTLC andn-Butanol: Ethyl acetate: Glacial acetic acid: Water (3:5:1:1) as mobile phaseon silica gel 60 F254 TLC plates. This led to the development of a validated standardization method using Berberine as a chemical marker, following the guidelines of USP and ICH. The R_f of Berberine was found to be 0.322 ± 0.010. In the calibration curve the linearity was found to be in the range of 10 to 90 ng/spot. The detection limit was 0.067 ng/spot, and the Limit of quantification was 8.62 ng/spot. The CV during intra-day and inter-day analysis were 3.3% and 1.96% respectively; this shows the precision. The recovery was calculated and was 85.94%; this shows accuracy. The method also shows specificity for Berberine. Thus a validated method for standardization of BSL-150 using Berberineas chemical marker was developed.