A selective and sensitive stability-indicating LC-MS/MS method, operated in ESI and quadrupole linear ion trap (QTRAP) modes, has been developed for the identification and structural characterization of stressed degradation products of indapamide.
Two new selective, precise, and accurate methods were developed for the determination of fenofibrate in the presence of its basic degradation product. In the first method fenofibrate was determined using an algorithm bivariate calibration derivative method, in which an optimum pair of wavelengths was chosen for the determination of different binary mixtures. In the second method (HPLC), separation was achieved on RESTEK Pinnacle II phenyl column (5 µm, 250 × 4.6 mm) and Pinnacle II phenyl (5 µm, 10 × 4 mm) guard cartridge using a mobile phase consisting of methanol -0.1% phosphoric acid (60:40, v/v) at a flow rate 2 mL·min -1 , and the column oven temperature was set at 50˚C. The UV detector was time programmed at 302 nm and 289 nm for the internal standard (I.S.) and fenofibrate, respectively. The proposed methods were successfully applied for the determination of fenofibrate and its degradation product in the laboratory-prepared mixture and in pharmaceutical formulation. The assay results obtained using the bivariate method were statistically compared to those of the HPLC method and good agreement was observed.
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