... years.
Today, preparative HPLC has also become a powerful technology in phar-
maceutical development and production either for isolation of impurities, for
937
HPLC for Pharmaceutical Scientists, Edited ... 0.003–0.1
semipreparative for toxicology
Semipreparative 10–40 Intermediates for 25–100 0.1–5
—preparative lab synthesis
Pilot plant 100–300 Manufacturing of 100–1000 20–5...
... metabolites are
important biotransformation pathways for many drugs and xenobiotics [127,
132, 133]. For example, the formation of acyl glucuronide conjugate forced the
withdrawal of four marketed ... intermediates
for formation of the keto acid, were also observed in the radiochromatogram
of rat plasma (spectrum not shown) [131].
PRACTICAL APPLICATIONS 335
Scheme 11. Mechanism for th...
... based on the forced transport of the polymer molecules through the porous
stationary-phase media under the conditions of suppressed interactions of the
263
HPLC for Pharmaceutical Scientists, ... in
reversed-phase chromatography applications for example, if the area% does
not agree with the assay% value for pharmaceutical analysis of a particular
active pharmaceutical ingredient...
... addition, forced decomposition studies must also be performed for dif-
ferent dosage forms (capsule, tablet, suspension, injectable, etc.) of the same
drug substance.
688 ROLE OF HPLC DURING FORMULATION ... (capsule dosage form) of
the development compound A with aspirin was proposed. The preformulation
TEST METHODS FOR MOST COMMON DOSAGE FORMS 689
Figure 15-2. HPLC chromatogram obtai...
... material. In that
sense, data generated using HPLC and hyphenated HPLC techniques such
as HPLC/ MS, HPLC- MS/MS, and HPLC/ NMR serve as the foundation for
declaring the existence of reproducible ... [7] guidelines for method validation, the existence of a
final synthetic process for the active pharmaceutical ingredients (APIs), and
final market image of the pharmaceutical dosa...