Stability Comparison
Posted: Fri Jul 21, 2006 11:36 am
Dear Experts,
I am currently doing stability studies of a drug in human plasma using HPLC-UV method.For stability comparison should I use nominal concentration or the peak area (response) ? If comparison using peak area(response) is acceptable then there is no need for me to prepare for a calibration curve in conducting stability assay?e.g Freeze and Thaw Stability: Compare the peak area of at least three aliquots of each low and high concentration of samples that undergo freeze and thaw cycle (3rd cycle) to freshly made samples (low and high concentration).
Note: Freshly made samples means that I prepare a freshly made stock solution,spiked a specific amount to plasma.
Please help.
I am currently doing stability studies of a drug in human plasma using HPLC-UV method.For stability comparison should I use nominal concentration or the peak area (response) ? If comparison using peak area(response) is acceptable then there is no need for me to prepare for a calibration curve in conducting stability assay?e.g Freeze and Thaw Stability: Compare the peak area of at least three aliquots of each low and high concentration of samples that undergo freeze and thaw cycle (3rd cycle) to freshly made samples (low and high concentration).
Note: Freshly made samples means that I prepare a freshly made stock solution,spiked a specific amount to plasma.
Please help.