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Aim: Our study includes the formulation
of 5-fluorouracil nanoformulation and identification of rapid, reactive and vigorous
analytical & bio analytical HPLC-UV method development & validation and
its application upon the pharmacokinetic study and determination of acute
toxicological profile of the drug in Sprague Dawley rats.

Background: 5-Fluorouracil
is an anti-cancerous drug use against many types of cancer. The nanoparticles
loaded drug has the ability to overcome the toxicity, low bioavailability,
short half-life and extend the efficacy on
the cancer cells. The HPLC-UV method used
to develop a simple & rapid validation for quantification determination
formulated formulation.

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Methodology: The
HPLC-UV method used to validate the
analytical method development in the expression
of specificity, sensitivity, precision, accuracy & stability and further
correlated with pharmacokinetics and toxicological profile of the 5-FU
nanoformulation on rat plasma. PLGA (poly-lactic-co-glycolic
acid) used as a polymer to hold 5-FU-in a nanoformulation by solvent
evaporation. The developed nanoparticles of 5-FU, evaluated on the basis of
particles size analysis, shape & surface morphology and further HPLC-UV
method have been employed for the validation of analytical & its
application over pharmacokinetic data collection.

Results: The
stable polymeric nanoformulation of 5-FU ranges the size of 137±0.95 to 195±0.96 nm and surface charges lie between 0.26±0.09 to 0.30±0.06 mv. The
pharmacokinetics drug profile of 5-FUNPs was
collected on the basis of validated HPLC-UV analytical method, highest peak
concentration, Cmax 3.25±0.75 mg/L at the highest time point, Tmax 7.21±2.50 hrs and the area
under the curve were 8.90±5.0 mg/L-h (AUC 0-96) & 9.50±3.4
mg/L-h (AUC 0-?). The t(1/2) was 21.65±4.45 hrs.

Interpretation:

Our
study concluded that 5-FU polymeric
nanoparticles show an informative
pharmacokinetic data to correlates with clinical findings, after the
formulation of nanoformulation the HPLC-UV spectroscopic analytical method were
successfully developed and validated and further applied over pharmacokinetics
study & toxicological data collected to optimize the safe drug
concentration for therapeutic effects.

Keywords: 5-fluorouracil,
HPLC-UV, nanoparticles, pharmacokinetics, PLGA.

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