Abstract:
A simple, accurate, precise and stability indicating RP-HPLC method was
developed and validated for estimation of Aliskiren Hemifumarate and
Amlodipine Besylate in bulk and tablet dosage form. The RP-HPLC method has
shown adequate separation for Aliskiren Hemifumarate and Amlodipine Besylate
from its degradation products. The separation was achieved on a enable ODS C18
(250mm X 4.6mm i.d., 5μm particle size) with an isocratic mixture of water:
acetonitrile pH-3.5 adjusted with o-phosphoric acid in the ratio of 45:55 v/v. The
mobile phase at a flow rate of 1.0ml/min, Injection volume 20μl and wavelength
of detection was kept at 235nm. The retention time for Aliskiren Hemifumarate
and Amlodipine Besylate was 4.027 min and 7.36 min respectively. The linearity
of the proposed method was investigated in the range of 30-150μg/mL and 2-
10μg/mL for Aliskiren Hemifumarate and Amlodipine Besylate, respectively. Correlation coefficient was 0.998 and 0.997 for Aliskiren Hemifumarate and
Amlodipine Besylate respectively. The limit of detection was 1.01μg/mL and
0.48μg/mL for Aliskiren Hemifumarate and Amlodipine Besylate respectively
and the limit of quantification was 3.06μg/mL and 1.47μg/mL for Aliskiren
Hemifumarate and Amlodipine Besylate, respectively. Forced degradation study
was carried out on combined dosage form as per ICH guideline and it was
exposed to hydrolysis (acid and base hydrolysis), oxidative, thermal and sunlight
conditions to apply stress. Proposed method was validated as per ICH guidelines
for linearity, accuracy, precision, specificity and robustness for estimation of
Aliskiren Hemifumarate and Amlodipine Besylate in commercially available
pharmaceutical dosage form and results were found to be satisfactory. Thus the
developed and validated stability indicating method can be used successfully for
marketed formulations.
