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Ibandronate sodium [(1-hydroxy-3-(methyl pentyl amino) propylidene bisphosphonic acid monosodium monohydrate)] is the
sodium salt of ibandronic acid, a synthetic nitrogen-containing bisphosphonate drug. This new, third generation bisphosphonate is
used in treatment of bone diseases like Pagetâ??s disease, malignant hypercalcemia and postmenopausal osteoporosis. A simple, accurate
and sensitive liquid chromatographic method has been developed for the assay of ibandronate sodium in tablet dosage form. The
separation was achieved on C18 (250x4.6 mm), 5 ?¼m chromatographic column. Mobile phase was mixture of 1 mL ortho-phosphoric
acid, 50 mL CH3CN, 0.96 g Na pentansulfonate and 0.1 g Na EDTA in 1000 mL H2O. Column temperature was 40 ?°C, mobile phase
flow rate 1.0 mL/min and detection wavelength 195 nm. The method was validated according to ICH Q2 (R1) requirements. It was
proved that method is specific for determination of ibandronate sodium. Linearity was confirmed with calculated r value (r=0.9996).
Accuracy was tested at three concentrations levels (80%, 100% and 120%) and confirmed by obtained Recovery values (98.40â??
99.89%). Precision was tested at two levels: intra-assay precision and intermediate precision. Calculated relative standard deviations
were 0.29% and 0.83%, respectively. Small variations of mobile phase composition (proportion of organic solvent, concentration of
ion pair reagent) and column temperature did not affect qualitative and quantitative system responses significantly, which proved
methodâ??s robustness. Applicability of the method was confirmed by analysis of commercially available tablets.
Biography
Ivkovi?? Branka has completed PhD from University of Belgrade, Faculty of Pharmacy, Department of Pharmaceutical Chemistry.