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Bioanalytical method development and validation for estimation of formulated sustained release tablet of Nateglinide in Rabbit plasma.
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| Author:
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AMIT KASABEA, AJIT S. KULKARNIB , VINOD L. GAIKWADC
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| Abstract:
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In house bioanalytical method was developed for the estimation of formulated sustained release tablet of Nateglinide
[NTG](F4, F8, F12 and F16), which varies in concentration of HPMC- K series polymer of controlled release grades in
Rabbit plasma to determine different pharmacokinetic parameters. For the development Jasco PU-2085 Plus with
quaternary gradient pump having UV/VIS detector was used. HPLC analysis was performed using a Hypersil ODS C18
(average particle size 5 mm) column (250 mm, 4.6 mm). The mobile phase [10 mM phosphate buffer (pH 6.8) and
acetonitrile (35:65 v/v)] was selected after extraction study. The eluent was monitored with the UV detector at
210nm with a flow rate of 1 mL/min and sample size of 20 µL. The Calibration curve was found to be linear for
concentration ranges between 100.74–3329.83 ng/mL. The retention times of NTG and internal standard (gliclazide)
were 9.60 min and 9.71 min respectively. The developed bioanalytical method was validated for accuracy and
precision and applied successfully to determine pharmacokinetic parameters.
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| Keyword:
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Nateglinide, bioanalytical method, pharmacokinetic parameters, PKSolver.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2019.11.01.040
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| Download:
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