-
- Posts: 1
- Joined: Mon Jan 30, 2012 1:54 pm
Dear all
I am developing a degradation product method for vitamins A (retinol palmitate) and D (cholecalciferol) ointment by HPLC-UV and I have a few questions about it. I know that HPLC-UV isn’t the most suitable technique for degradation product, but it’s the only one available for me at the moment.
Is it necessary to submit the sample to acid and basic hydrolysis once the ointment is a 100% oil base, and since there’s no water there’s no source of hydrolysis? And if it’s necessary, how could I do that, because I extract my sample with n-hexane and most of basis are water-based and wouldn’t mix with the ointment.
The second point is how to establish limits to vitamins degradation products. Here in Brazil there’s no guidance for degradation products of vitamins and ICH guides don’t applies to vitamins. Once I won’t be able to characterize the degradation product I could obtain, Which limits should I use?
Best wishes
Thank you all
Willaine Costa
I am developing a degradation product method for vitamins A (retinol palmitate) and D (cholecalciferol) ointment by HPLC-UV and I have a few questions about it. I know that HPLC-UV isn’t the most suitable technique for degradation product, but it’s the only one available for me at the moment.
Is it necessary to submit the sample to acid and basic hydrolysis once the ointment is a 100% oil base, and since there’s no water there’s no source of hydrolysis? And if it’s necessary, how could I do that, because I extract my sample with n-hexane and most of basis are water-based and wouldn’t mix with the ointment.
The second point is how to establish limits to vitamins degradation products. Here in Brazil there’s no guidance for degradation products of vitamins and ICH guides don’t applies to vitamins. Once I won’t be able to characterize the degradation product I could obtain, Which limits should I use?
Best wishes
Thank you all
Willaine Costa
