Standardization of Some Commercial Anti-diabetic Herbal Products containing Syzygiumcumini

Abstract

An isocratic HPLC method was developed for standardization of five commercially available products containing S. cumini seeds (DIABECON, MADHULENE, HYPONIDD, D-FIT and DIABEGON)using methylxanthoxylin (MXX)as marker. The method was validated in accordance with ICH Q2(R1) guidelines. The chromatographic separation of MXX was achieved on a C18 column by mobile phase composed of methanol and water (60:40%v/v) at a flow rate 0.5 mL/min. The eluent was detected at 280 nm. The method was linear over concentration of 1-200 μg/mL with correlation coefficient of 0.9999. The LOD and LOQ were 0.175 and 0.530 µg/mL, respectively. The method was precise (%RSD <0.31), accurate and robust for determination of MXX in herbal extracts. The content of MXX in the seed extract was found to be 0.0433%w/w while it was ranging from 0.026- 0.041%w/w in the products. The content of MXX was found to be equivalent to the pure seed extract only in DIABECON tablets and D-FIT soft gelatine capsules while it was found to be significantly less in the other formulations.