Specificity for Normal phase hplc Methods

[bhaskarac]

Can anybody help me in clarifying following queries.

a)what is the procedure to be adopted for carrying out the specificity studies for a normal phase HPLC method.

b)Also please explain is it required to carry out the degradation studies for a chiral HPLC method?

Thanks in advance,

Bhaskar

[Carlos Teixeira]

Dear Bhaskarac

In my opinion:

1 - You can performing Specificity Studies on Normal Phase with the same procedures that You use for Reverse Phase, follow the Guidelines of ICH *(Validation of Analytical Methods: Q2A and Q2B0. We have to consider that these rules are applicable to many analytical technics.

2 - Think with me: if you are using a Chiral HPLC method so your analyte show chirality or enantiomerism properties: you have to performing the degradation studies (use ICH Guidelines, too) because you can evaluate the (probable) existence of degradant substance that respond positivally on chiral method.

Have Good Elutions!!!

Carlos Teixeira

Note: Your county is very exciting!!!
(*) = www.ich.org

[bhaskarac]

In the cases where a product is having two methods one for related substances by one method and only enantiomers by other method, any way we are checking the Forced degradation studies in Related substances method, is this required to study degradation studies even in chiral method, as we are able to get only chiral impurities?

Thanks,

Bhaskar