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I am working on a project called Ursodiol. This is a bile salt acid
present in a body. While developing a LC-MSMS method we find blank
response from endogeneous ursodiol. Somewhat we could screen several
lots and could get blanks having urso less than 20% of standard A
(LLOQ). However the BE criteria is on total ursodiol. To get this we
need to hydrolyse the plasma again with the enzyme disoolved in pH5.6
sodium acatate buffer. When plasma with GDCA and TDCA is hydrolysed we
are getting 50% more urso than Standard A. Could anybody suggest any
way of getting rid of this blank endogeneous baseline. We have tried
individual quantification of urso, gdca and tdca, but we are not sure
about regulatory rection on it.
Appreciate comments on this.
Thanks
Krishna
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