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

Abstract

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.

A newly developed and fully validated HPLC method for simultenous determination of in-situ single pass intestinal permeability of domperidone, metoprolol tartarate and phenol red

“…A review of the literature reveals that analysis of DMP was accomplished with using separation techniques such as high-performance liquid chromatography (HPLC) [10,11], capillary electrophoresis [12], ultra-violet (UV) spectrometry [13], and LC-MS/MS [14][15][16] was also used. Among these, HPLC is the dominant technique because it allows quantitative determination in many different matrices.…”

“…A perfusion solution containing the marker phenol red was administered for 60 minutes at a flow rate of 0.2 mL/min after the cannulated intestinal section had been cleaned and disinfected. At 10-minute intervals (10,20,30,40,50, and 60 minutes), samples were obtained from the distal region of the jejunum and placed in tubes. The samples were immediately frozen at -20°C to analyze with using HPLC.…”

Development and validation of reversed phase high performance liquid chromatography (RP-HPLC) for quantification of captopril in rabbit plasma

“…Radioimmunoassay (RIA) and enzyme immunoassay methods are complicated, and involve specialized and expensive equipment that are not generally available in all scientific settings and required high quantity of plasma which is not easily available in all populations. Among these methods, reversed phase high performance liquid chromatography (RP-HPLC) is the mostly used because of high sensitivity and selectivity and economical [19][20][21].…”

Validation and Quantification of Domperidone in Spiked Plasma Matrix Using Reversed Phase HPLC-UV Method

“…There are several reports exhibit various methods for quantifying domperidone in plasma matrices. The methods implement a high liquid chromatography approach coupled with UV (HPLC-UV), fluorescence, or tandem mass spectrometry (HPLC-MS/MS) detection [2][3][4][5][6][7][8][9][10][11][12]. Other reports applied the ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) [13][14] and the ultra-fast liquid chromatography (UFLC) method with fluorescence detection [15].…”