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O c t o b e r 1 9 - 2 0 , 2 0 1 8 | T o k y o , J a p a n
Pharma Congress 2018 & Molecular Medicine 2018
& Psychiatric Disorders 2018
Asian Journal of Biomedical and Pharmaceutical Sciences
|
ISSN: 2249-622X
|
Volume 8
International Conference on
PHARMACEUTICS AND NOVEL DRUG DELIVERY SYSTEMS
19
th
International Conference on
CELLULAR AND MOLECULAR MEDICINE
19
th
Annual Congress on
PSYCHIATRY AND PSYCHIATRIC DISORDERS
&
&
OF EXCELLENCE
IN INTERNATIONAL
MEETINGS
alliedacademies.comYEARS
Asian J Biomed Pharmaceut Sci 2018, Volume 8 | DOI: 10.4066/2249-622X-C3-009
BIO-ANALYTICAL METHODS FOR QUANTITATIVE DETERMINATION
(BIO-EQUIVALENCE AND BIO-AVAILABILITY) OF DRUG PRESENT IN THE
BLOOD MATRIX
Aashna Lamba and Swastika Mishra
Amity University, India
B
io-analytical methods utilized for the quantitative determination of drugs and their metabolite in biological matrix such as,
plasma, urine, saliva and serum in order to find their significant role in evaluation of interpretation of bioavailability and bio-
equivalence for Pharmacokinetic data. The evaluations for linearity, precisions, accuracy and sensitivity were performed on three
batches of spiked plasma samples. Each batch of spiked plasma sample included one complete set of calibration standards
(blank, blank plus internal standard etc). Each different blank matrix batches were screened for interference at the retention time
(RT). Bulk spiking of the samples were prepared by several dilution with analyte free plasma to obtain eight different concentra-
tion level. The closeness of the mean test results obtained by method to the true value (concentration) of the analyte showed
the precision of the analytical method. Accuracy was determined by replicate analysis of samples. Large set of low, middle and
high quality control (QC) samples were processed and analyzed against a single calibration curve. The following pharmacokinetic
parameters were calculated for analyte using software- AUC0-t, AUC0-24, AUC-∞, AUC%, Cmax, Tmax and T1/2.