A NEW RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF SACUBITRIL AND VALSARTAN IN ITS BULK AND TABLET DOSAGE FORM AND ITS FORCE DEGADATION STUDIES AS PER ICH
S. K. Godasu* and S. A. Sreenivas
ABSTRACT
A New method was established for simultaneous estimation of Sacubitril And Valsartan by RP-HPLC method.
Chromatographic separations were carried using Inertsil ODS (4.6 x 150 mm, 5μm) column with a mobile phase
composition of 0.1% OPA buffer and Acetonitrile(50:50) have been delivered at a flow rate of 1ml/min and the
detection was carried out using waters HPLC auto sampler, separation module 2695 with PDA detector 2996 at
wavelength 271 nm. The retention time for Sacubitril and Valsartan were 2.119 and 2.730 minute respectively.
The correlation coefficient values in linearity were found to be 0.999 and concentration range 12-60 μg/ml for
Sacubitril and 13-65μg/ml for Valsartan respectively. For accuracy The total recovery was found to be 100.30%
and 100.22% for Sacubitril and Valsartan. The LOD and LOQ for Sacubitril was found to be 2.96 and 9.96 and
LOD and LOQ for Valsartan was found to be 2.98 and 9.98. The force degradation studies were performed and the
results are within the limits. The results of study showed that the proposed RP‐HPLC method is a simple, accurate,
precise, rugged, robust, fast and reproducible, which may be useful for the routine estimation of Sacubitril and
Valsartan in pharmaceutical dosage form.
Keywords: Sacubitril, Valsartan, RP?HPLC, Simultaneous estimation.
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