Author(s): Krishna R. Gupta and Kiran N. Kale
A stability-indicating LC assay method was developed for the quantitative determination of Aliskiren (ALISK) in pharmaceutical dosage forms. Chromatographic separation was achieved on Hyperchrom- ODS 5µ C18 column (250 X 4.6 mm). The mobile phase was prepared by mixing Acetonitrile and 0.05 M KH2PO4 Buffer (45:55v/v) and pH was adjusted to 2.5 with 10% Ortho –phosphoric acid. The flow rate was 1.0mL/min with detection wavelength 280nm. Aliskiren degraded in acidic and alkaline conditions, while it was more stable in neutral, oxidative, thermal and photolytic conditions. The described method was linear over a range of 10-60 μg/mL for determination of Aliskiren (r=0.9989) .The developed method was successfully validated according to ICH Guidelines. The mean recovery was found to be 99.96%. The method was found to be suitable for analysis in presence of its degradation products.