Box-Behnken Assisted Validation and Optimization of an RP-HPLC Method for Simultaneous Determination of Domperidone and Lansoprazole
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 ph...
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MDPI AG
2021-01-01
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| Online Access: | https://www.mdpi.com/2297-8739/8/1/5 |
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| author | Mohd Afzal Mohd. Muddassir Abdullah Alarifi Mohammed Tahir Ansari |
| author_facet | Mohd Afzal Mohd. Muddassir Abdullah Alarifi Mohammed Tahir Ansari |
| author_sort | Mohd Afzal |
| collection | DOAJ |
| description | 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 <i>v</i>/<i>v</i>), pH 6.7. The flow rate was 1 mL·min<sup>−1</sup> with UV detection at 289 nm. Linearity was observed within the range of 4–36 µg·mL<sup>−1</sup> for domperidone and 2–18 µg·mL<sup>−1</sup> 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 (Y<sub>1</sub> and Y<sub>3</sub>) and the peak area (Y<sub>2</sub> and Y<sub>4</sub>) 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. |
| first_indexed | 2024-03-10T13:27:17Z |
| format | Article |
| id | doaj.art-a31b8a8b2a6f49059124d42f78983aac |
| institution | Directory Open Access Journal |
| issn | 2297-8739 |
| language | English |
| last_indexed | 2024-03-10T13:27:17Z |
| publishDate | 2021-01-01 |
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| spelling | doaj.art-a31b8a8b2a6f49059124d42f78983aac2023-11-21T08:42:51ZengMDPI AGSeparations2297-87392021-01-0181510.3390/separations8010005Box-Behnken Assisted Validation and Optimization of an RP-HPLC Method for Simultaneous Determination of Domperidone and LansoprazoleMohd Afzal0Mohd. Muddassir1Abdullah Alarifi2Mohammed Tahir Ansari3Department of Chemistry, College of Science, King Saud University, Riyadh 11451, Saudi ArabiaDepartment of Chemistry, College of Science, King Saud University, Riyadh 11451, Saudi ArabiaDepartment of Chemistry, College of Science, King Saud University, Riyadh 11451, Saudi ArabiaDepartment of Pharmaceutical Technology, Faculty of Pharmacy and Health Sciences, Universiti Kuala Lumpur Royal College of Medicine Perak, Ipoh 31400, MalaysiaA 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 <i>v</i>/<i>v</i>), pH 6.7. The flow rate was 1 mL·min<sup>−1</sup> with UV detection at 289 nm. Linearity was observed within the range of 4–36 µg·mL<sup>−1</sup> for domperidone and 2–18 µg·mL<sup>−1</sup> 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 (Y<sub>1</sub> and Y<sub>3</sub>) and the peak area (Y<sub>2</sub> and Y<sub>4</sub>) 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.https://www.mdpi.com/2297-8739/8/1/5lansoprazoledomperidonemethod validationBox–Behnkenchromatography |
| spellingShingle | Mohd Afzal Mohd. Muddassir Abdullah Alarifi Mohammed Tahir Ansari Box-Behnken Assisted Validation and Optimization of an RP-HPLC Method for Simultaneous Determination of Domperidone and Lansoprazole Separations lansoprazole domperidone method validation Box–Behnken chromatography |
| title | Box-Behnken Assisted Validation and Optimization of an RP-HPLC Method for Simultaneous Determination of Domperidone and Lansoprazole |
| title_full | Box-Behnken Assisted Validation and Optimization of an RP-HPLC Method for Simultaneous Determination of Domperidone and Lansoprazole |
| title_fullStr | Box-Behnken Assisted Validation and Optimization of an RP-HPLC Method for Simultaneous Determination of Domperidone and Lansoprazole |
| title_full_unstemmed | Box-Behnken Assisted Validation and Optimization of an RP-HPLC Method for Simultaneous Determination of Domperidone and Lansoprazole |
| title_short | Box-Behnken Assisted Validation and Optimization of an RP-HPLC Method for Simultaneous Determination of Domperidone and Lansoprazole |
| title_sort | box behnken assisted validation and optimization of an rp hplc method for simultaneous determination of domperidone and lansoprazole |
| topic | lansoprazole domperidone method validation Box–Behnken chromatography |
| url | https://www.mdpi.com/2297-8739/8/1/5 |
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