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The following message was posted to: PharmPK
I will highly appreciate in getting information about
drug stability studies in simulated gastric and
intestinal fluids, including study protocols and drug
extraction. Any references will be very helpful.
Thanks
Ananda
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Hi Ananda
You can refer USP for the preparation of simulated gastric fluid and
intestinal fluid. Dissolve the test item (50-100 ug/ml)in the simulated
fluids(in case of good water solubility)or use 5-10% organic solovent
like methanol and acetonitrile to dissolve the test item in same.Keep
spiked solution aliqouts at 37 degree C for desired stability period
and dilute appropriately with water or mobile phase at the time of
analysis. In case of HPLC analysis you can go for direct injection
without applying extraction procedure.
Hope this will help you.
Jignesh K.
Torrent Pharm. Ltd.
India.
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The following message was posted to: PharmPK
Hi
You can also refer to following papers
European J. Pharmaceutical Science 19 (2003)105-113
International Journal of Pharmaceutics 257 (2003) 97-102
R. C. Gupta
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (david@boomer.org)