Box-Behnken Assisted Validation and Optimization of an RP-HPLC Method for Simultaneous Determination of Domperidone and Lansoprazole

Abstract

A highly specific, accurate, and simple RP-HPLC technique was developed for the real-time quantification of domperidone (DOMP) and lansoprazole (LANS) in commercial formulations. Chromatographic studies were performed using a Luna C8(2), 5 μm, 100Å, column (250 × 4.6 mm, Phenomenex) with a mobile phase composed of acetonitrile/2 mM ammonium acetate (51:49 v/v), pH 6.7. The flow rate was 1 mL·min−1 with UV detection at 289 nm. Linearity was observed within the range of 4–36 µg·mL−1 for domperidone and 2–18 µg·mL−1 for lansoprazole. Method optimization was achieved using Box-Behnken design software, in which three key variables were examined, namely, the flow rate (A), the composition of the mobile phase (B), and the pH (C). The retention time (Y1 and Y3) and the peak area (Y2 and Y4) were taken as the response parameters. We observed that slight alterations in the mobile phase and the flow rate influenced the outcome, whereas the pH exerted no effect. Method validation featured various ICH parameters including linearity, limit of detection (LOD), accuracy, precision, ruggedness, robustness, stability, and system suitability. This method is potentially useful for the analysis of commercial formulations and laboratory preparations.

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.…”

Green analytical quality by design RP-HPLC technique with fluorimetric detection for simultaneous assay of cinnarizine and dompridone

“…Numerous analytical techniques were developed to determine both drugs either alone or combined with other drugs, such as liquid chromatography (LC) [5][6][7][8][9][10], spectrophotometry [11][12][13][14], spectrofluorimetry [8,15], capillary electrophoresis [16][17][18] and electrochemical analysis [19][20][21], for CRZ and DPN.…”

The Applicability of Chromatographic Retention Modeling on Chiral Stationary Phases in Reverse-Phase Mode: A Case Study for Ezetimibe and Its Impurities

“…The main advantage of employing an "enhanced approach" through software-assisted method development is acquiring an understanding of the process through the identification of critical method parameters (CMPs or ECs) and critical quality attributes (CQAs), which are essential for establishing a control strategy. There are numerous examples from recent years about the applicability of experimental design-based retention modeling in chromatographic method development and optimization using both empirical-model-based, statistical- [2,4,[12][13][14][15][16][17][18][19][20][21] and theoretical-model-based, or mechanistic [8,[22][23][24][25][26] approaches.…”