Question { Apex, 23494 }

Why forced degradation studies are performed in hplc method
validation?

Answer

is nothing but the study to assess specificity of the
analytical method by forcibly degrading the analyte
(Eg:exposure to temperauremore than accelerated conditions,
higher humidity and light, wide range of pH and oxidation)

Methodology :
Analyte should be exposed to the above said conditions and
analyse as per the testing methods.

Observatoin :
by applying the above stress conditions, new impurities and
degradants will be formed. the degradants should be well
seperated from the main analyte.

Scope and conculsion :
to prove the testing methods are good that can seperate all
the impurities from the analyte
(i.e stabilily indicating analytical methods) and
degradation path way can be established.

Note:we will come to know the impurities formation during
the stability storage for a period of time. if it is due to
storage, then it should be evaluated.


Best regards,
Bujji Kanchi.