Determination of the anti-osteoporosis drug ipriflavone in pharmaceutical formulation by stripping voltammetric and chromatographic methods.

Ipriflavone is a nonhormonal isoflavone derivative currently used as a bone-building agent for prevention and treatment of postmenopausal osteoporosis. Ipriflavone was reduced at the hanging mercury drop electrode in buffers of pH 2-11 via the consumption of 2 electrons corresponding to the reduction of the C=O double bond in the C 4 position of the analyte molecule. A fully validated square-wave adsorptive cathodic stripping (SW-AdCS) voltammetric method was described for the trace quantification of bulk ipriflavone, A linear response, with concentrations of bulk ipriflavone over the range 5 x 10(-9)-4 x 10(-7) M with a limit of detection of 1.5 x 10(-9) M bulk ipriflavone, was obtained. Moreover, an LC-UV detection method was also described for determining ipriflavone. The peak area was proportional to the concentration of bulk ipriflavone over the range 1 x 10(-7)-1 x 10(-4) M with a limit of detection of 3 x 10(-8) M. The described SW-AdCS voltammetric and LC methods were successfully applied for the assay of ipriflavone in iprivone tablets without interference from excipients. Accuracy and precision of both methods for determination of ipriflavone in its tablets were studied and discussed.