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A simple, specific and sensitive RP-HPLC method was developed and validated for simultaneous estimation of aliskiren
hemifumarate and valsartan in combination. The RP-HPLC method has shown adequate separation of aliskiren hemifumarate
and valsartan from its mixture. The separation was achieved on a phenomenex luna ODS C
18
(250 mm X 4.6 mm i.d., 5 μm particle
size) with an gradient system of Water: Methanol in the ratio of 60:40 v/v. The mobile phase was run at a flow rate of 1.0 ml/min
using 20 μl injection volume at 250 nm as wavelength of detection. The retention time for aliskiren hemifumarate and valsartan
was obtained as 1.843±0.1 min and 3.197±0.2 min, respectively. The linearity of the proposed method was investigated in the
range of 5-25 μg/ml and 5-25 μg/ml for aliskiren hemifumarate and valsartan respectively. Correlation coefficient was 0.9980 and
0.9990 for aliskiren hemifumarate and valsartan, respectively. The developed method was validated as per ICH guideline, for its
accuracy, precision, LOD & LOQ values. The results were found to be satisfactory, thus the method is specific, rapid and simple
with good sensitivity for estimation of aliskiren hemifumarate and valsartan. The developed and validated analytical method is
cost effective and reproducible even in ordinary laboratories thus suitable to analyse both drugs simultaneously in bulk as well as
in marketed formulation.
Biography
Suresh Jain has completed his Ph.D. from Jodhpur University, Rajasthan, India in year 2011. He is working as an Associate Professor in MM
University, Ambala, a premier university of India. He has published 14 research papers in various journals of repute and has been serving as reviewer
of various journal of repute including Elsevier.
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