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Page 101
Chromatography 2016
September 21-23, 2016
Volume 7, Issue 5(Suppl) J Chromatogr Sep Tech 2016
ISSN: 2157-7064 JCGST, an open access journal
conferenceseries .com
September 21-23, 2016 Amsterdam, Netherlands
World Congress on Chromatography
J Chromatogr Sep Tech 2016, 7:5(Suppl)
Setting acceptance criteria for validation of chromatographicmethods of drug eluting stents:Minimum
requirements for analytical variability
Marika Kamberi
Abbott Vascular, Inc., USA
C hromatographic methods are commonly used for the analysis of drug eluting stents (DESs). Accuracy and reliability of
the analytical results are crucial for ensuring quality, safety and efficacy of DESs. Method validation is the process used to
confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results frommethod validation
can be used to judge the quality, reliability and consistency of analytical results. Validation of analytical methods includes
the identification of the performance parameters relevant for the given procedure, the definition of appropriate acceptance
criteria and the appropriate design of the validation studies. Achieving an appropriate consideration of the analytical variability
in assay procedures and setting acceptance criteria for analytical validations is however much more difficult than usually
described. Criteria which are too wide may lead to unnecessary and incorrect out-of-specification (OOS) cases, resulting in
bad reject decision for products. This study concentrates on analysis, through simulation, of the relation of method variability
with specification limits for the total loaded dose of the active substance on the DES. The findings of this study point what
levels of precision and accuracy are needed, in other words what is the magnitude of the allowable total error from all possible
effects (both systematic and random) in an assay method in order to achieve the level of performance required for the methods
applied routinely for the evaluation of the total loaded dose of DES as part of lot release/stability testing.
Ciprofloxacin residue and their impact on biomolecules in eggs of laying hens following oral administration
Md Mustahsan Billah1, S M Masud Rana2 and Mohammad Salim Hossain2
1Dhaka International University, Bangladesh
2Noakhali Science and Technology University, Bangladesh
The present study was designed to evaluate ciprofloxacin residue and their impact on some biomolecules (albumin, total
protein and cholesterol) in eggs of laying hens after oral administration. For that purpose, One group (A) of laying hens
(n = 20) were orally administered 10 mg⁄kg ciprofloxacin for five consecutive days. The second group (n = 10) was untreated
controls. Eggs were collected from day one of treatment and up to 25 days after withdrawal of treatment. Egg white and
yolk from each egg were separated, and ciprofloxacin residues and biomolecules were analyzed by high-performance liquid
chromatography method with fluorescence detection and humalyzer having commercial assay kits respectively. Ciprofloxacin
was detectable in egg white on the first day of treatment in higher concentrations (1755 µg⁄kg) while at lower concentrations
(362 µg⁄kg) in egg yolk. In both medium, concentrations increased during five days treatment period. After withdrawal of
treatment, eight days and fourteen days were required to deplete the drug residue below the established LOD in albumen
and yolk respectively. On the other hand, cholesterol level increased while albumin and total protein level decreased during
treatment period. All these biomolecules returns to their normal level at about seventeenth or eighteenth day from the day of
treatment. In all cases, the differences in drug residue concentrations and biomolecules concentrations during treatment and
post treatment in egg were found significant. Based on the time needed for residue to deplete below the LOD, we can estimate
that, within twenty days of treatment period, egg contents could contain harmful residue which can deplete the nutritional
value of egg and thus could cause severe disease for consumer as well whereas it is safe after that period.