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Development and validation of high-performance liquid chromatography method for the simultaneous monitoring of pantoprazole sodium sesquihydrate and domperidone maleate in plasma and its application to pharmacokinetic study

Abbas Ghulam, Saadullah Malik, Rasul Akhtar, Shah Shahid, Khan Sajid Mehmood, Hanif Muhammad, Ahmed Muhammad Masood

Acta Chromatographica

2020

Vol. 32, no. 3

157--165

A sensitive, inexpensive high-performance liquid chromatography–ultraviolet detection (HPLC–UV) method has been developed and validated for the simultaneous monitoring of pantoprazole sodium sesquihydrate (PSS) and domperidone maleate (DM) in rabbit plasma on a C18 column with UV detection at 285 nm. Box–Behnken design was used with 3 independent variables, namely, flow rate (X1), mobile phase composition (X2), and phosphate buffer pH (X3), which were used to design mathematical models. Response surface design was applied to optimize the dependent variables, i.e., retention time (Y1 and Y2) and percentage recoveries (Y3 and Y4) of PSS and DM. The method was sensitive and reproducible over 1.562 to 25 μg/mL. The effect of the quadratic outcome of flow rate, mobile phase composition, and buffer pH on retention time (p ˂ 0.001) and percentage recoveries of PSS and DM (p = 0.0016) were significant. The regression values obtained from analytical curve of PSS and DM were 0.999 and 0.9994, respectively. The percentage recoveries of PSS and DM were ranged from 94.5 to 100.41% and 94.77 to 100.31%, respectively. The developed method was applied for studying the pharmacokinetics of PSS and DM. The Cmax of test and reference formulations were 48.06 ± 0.347 μg/mL and 46.31 ± 0.398 μg/mL for PSS, and 15.11 ± 1.608 μg/mL and 12.06 ± 1.234 μg/mL for DM, respectively.

Computer-assisted optimization of liquid-liquid extraction for HPLC analysis of domperidone and pantoprazole in human plasma

Sivakumar T., Manavalan R., Valliappan K.

Acta Chromatographica

2008

Vol. 20, no. 4

549-562

This paper deals with optimization of a liquid-liquid extraction procedure for simultaneous HPLC analysis of domperidone and pantoprazole in human plasma. Central composite design and Derringer’s desirability function were used to optimize the concentration of KOH and the volume of ethyl acetate as the main factors affecting the liquid-liquid extraction procedure. After extraction, the analytes were separated quantitatively on a C 18 column with 10 mM pH 7.0 phosphate buffer-methanol-acetonitrile 48.46:20:31.54 ( υ / υ ) as mobile phase at a flow rate of 1.20 mL min -1 and with UV detection at 285 nm. It was concluded that extraction recovery of both the analytes was affected by KOH concentration and that recovery of pantoprazole was affected by ethyl acetate (extraction solvent) volume. Extraction recovery under optimum extraction conditions was 93.52% for domperidone and 92.72% for pantoprazole. The optimized extraction method was validated. Linearity was established for six levels in the ranges 10–1000 ng mL -1 for pantoprazole and 15–1000 ng mL -1 for domperidone. The lower limit of quantitation (LLOQ) and detection (LOD) were estimated as 9.84 and 5.91 ng mL -1 , respectively, for pantoprazole and 14.56 and 8.79 ng mL -1 for domperidone. The optimized method was linear, specific, accurate, and precise; the high recovery (>92%) and low relative standard deviation (<2.5%) enable reliable quantification of these analytes in spiked human plasma.