assay development Flashcards
define accuracy
how close the measured value and true value.It will determine validity of data
what is validation
activity to verify the method use suitable for intended application
main criteria for validation
reproducibility,repeatibility,precision
accurancy
sensitivity to lod and loq
what is assay
the testing or measurement technique
method or procedure
what cause drug decomposition
- hydrolysis
- oxidation
- photolysis
describe hydrolysis
due to presence of oxygen
use air tight container
eg:ester, amide, lactams
oxidation
due to presence of oxidation agent
presence of trace element as catalyst
can be prevented by using antioxidant
eg;vitamin c,vitamin a, morphine,tetracycline
photolysis
due to electromagnectic radiation mainly uv
prevented by suitable packaging &antioxidant
eg:vitamin C,folic acid,riboflavin
drug cecomposition product
depend on drug and way of decomposed
drug decomposition assay
- visual test
2. chemical/physical test