Box-behnken design assisted protein precipitation optimization for simultaneous determination of metformin hydrochloride and alogliptin benzoate in plasma along with harmacokinetic application
By: Patel, H. P
.
Contributor(s): Patel, D. P.
Publisher: Mumbai Indian Journal of Pharmaceutical Science 2021Edition: Vol.83(4), July-Aug.Description: 785-793p.Subject(s): PHARMACEUTICSOnline resources: Click here
In:
Indian journal of pharmaceutical sciencesSummary: The study focuses on systematic quality by design oriented approach for the optimization of a sensitive
reverse phase liquid chromatographic bioanalytical method for determination of metformin hydrochloride
and alogliptin benzoate in plasma along with its validation. Chromatographic separation was carried out
on C18 column using gradient mode with mobile phase; 1-octane sulphonic acid (10 mM), acetonitrile
and phosphate buffer pH 4, adjusted by orthophosphoric acid, at 1.0 ml/min using 235 nm as detection
wavelength. A Box–Behnken design was applied to protein precipitation sample extraction method with
centrifugation speed, centrifugation time and volume of plasma as the critical method parameters for
maximizing percentage extraction recovery of metformin hydrochloride and alogliptin benzoate as the
critical analytical attributes. The optimized condition for centrifugation speed, centrifugation time and
volume of plasma considered as the critical method parameters for maximizing extraction recovery were
11 800 rpm, 15 min, 100 μl. This optimized extraction method gave clear samples and resulted in good
correlation in the concentration range of 0.022-2.2 and 0.0012-0.12 μg/ml for metformin hydrochloride
and alogliptin benzoate, respectively. The mean percentage extraction recoveries at three quality control
levels were 90.83-95.87 % for metformin hydrochloride and 94.03-96.73 % for alogliptin benzoate. The
plasma concentration time profile showed higher peak plasma concentration for formulation compared
to pure drugs indicating that absorption of metformin and alogliptin hydrochloride from formulation
was better. The developed liquid chromatographic method presented good quantitative capability, good
linearity, higher extraction recovery, simpler operation and short analysis time with low cost.
| Item type | Current location | Call number | Status | Date due | Barcode | Item holds |
|---|---|---|---|---|---|---|
Articles Abstract Database
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School of Pharmacy Archieval Section | Not for loan | 2022-0932 |
The study focuses on systematic quality by design oriented approach for the optimization of a sensitive
reverse phase liquid chromatographic bioanalytical method for determination of metformin hydrochloride
and alogliptin benzoate in plasma along with its validation. Chromatographic separation was carried out
on C18 column using gradient mode with mobile phase; 1-octane sulphonic acid (10 mM), acetonitrile
and phosphate buffer pH 4, adjusted by orthophosphoric acid, at 1.0 ml/min using 235 nm as detection
wavelength. A Box–Behnken design was applied to protein precipitation sample extraction method with
centrifugation speed, centrifugation time and volume of plasma as the critical method parameters for
maximizing percentage extraction recovery of metformin hydrochloride and alogliptin benzoate as the
critical analytical attributes. The optimized condition for centrifugation speed, centrifugation time and
volume of plasma considered as the critical method parameters for maximizing extraction recovery were
11 800 rpm, 15 min, 100 μl. This optimized extraction method gave clear samples and resulted in good
correlation in the concentration range of 0.022-2.2 and 0.0012-0.12 μg/ml for metformin hydrochloride
and alogliptin benzoate, respectively. The mean percentage extraction recoveries at three quality control
levels were 90.83-95.87 % for metformin hydrochloride and 94.03-96.73 % for alogliptin benzoate. The
plasma concentration time profile showed higher peak plasma concentration for formulation compared
to pure drugs indicating that absorption of metformin and alogliptin hydrochloride from formulation
was better. The developed liquid chromatographic method presented good quantitative capability, good
linearity, higher extraction recovery, simpler operation and short analysis time with low cost.
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