Sodium Sacubitril and valsartan 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 salts 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 90°C), hydrogen peroxide (H2O2). The effect of light, moisture and heat on the stability of salts complex of sacubitril and sodium valsartan 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 [250-600μg /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.
Homs University Journal.
2019.