Abstract

STUDY OF SOME STABILITY CONDITIONS SACUBITRIL AND VALSARTAN SODIUM SALT COMPLEX (RAW MATERIAL)

Walaa Salamah* and Issa Alsalloum

ABSTRACT

Sacubitril and Valsartan Sodium Salt complex is recently approved in Syria. This study was conducted using the HPLC method. The validity and reliability of this method was verified, it is also verified as stability indicator. The stability of the salt complex solution of Sacubitril and Valsartan was studied when exposed to stress conditions to obtain the degradation products. These conditions include the addition of concentrated Hydrochloric acid (HCl), Sodium Hydroxide (NaOH) (associated with high temperature up to 90⁰C), Hydrogen Peroxide (H2O2). The effect of light on the stability of Sacubitril and Valsartan Sodium salts complex of powder. The samples were analyzed using column C18 [250 mm x 4.6 mm]. The mobile phase was a mixture of acetonitrile 49 part: water 50 part: 1part glacial acetic acid) and UV detector at 265 nm wavelength. The method showed a good identification of Sacubitril and Valsartan peaks from degradation product peaks ones, where the retention time of the Valsartan was 6.1 min and of the Sacubitril 8.6 min. The method was linear on the range [250-600 μg/ml], the regression coefficient was R2= 0.9994 for Sacubitril and R² = 0.9998 for Valsartan. The study concludes to avoid the degradation factors of Sacubitril and Valsartan Sodium Salt Complex during the preparation and surveillance in the pharmaceutical industry.

Keywords: HPLC, Sacubitril and Valsartan Sodium Salt Complex, Sacubitril, Valsartan, Stress conditions.