RP-HPLC-Based Bioanalytical Approach for Simultaneous Quantitation of Cinnarizine and Domperidone in Rat Plasma
An accurate, precise and sensitive reverse-phase high-performance liquid chromatography (RP-HPLC) bioanalytical approach was developed for the simultaneous estimation of cinnarizine (CIN) and domperidone (DOM) in rat plasma using irbesartan (IRB) as an internal standard (IS). The proposed RP-HPLC ap...
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MDPI AG
2023-02-01
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| Online Access: | https://www.mdpi.com/2297-8739/10/3/159 |
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| author | Mohit Vij Neha Dand Lalit Kumar Amardeep Ankalgi Pankaj Wadhwa Sultan Alshehri Faiyaz Shakeel Mohammed M. Ghoneim Prawez Alam Shahid Ud Din Wani |
| author_facet | Mohit Vij Neha Dand Lalit Kumar Amardeep Ankalgi Pankaj Wadhwa Sultan Alshehri Faiyaz Shakeel Mohammed M. Ghoneim Prawez Alam Shahid Ud Din Wani |
| author_sort | Mohit Vij |
| collection | DOAJ |
| description | An accurate, precise and sensitive reverse-phase high-performance liquid chromatography (RP-HPLC) bioanalytical approach was developed for the simultaneous estimation of cinnarizine (CIN) and domperidone (DOM) in rat plasma using irbesartan (IRB) as an internal standard (IS). The proposed RP-HPLC approach was validated as per the latest ICH M10 guidelines. The analytes (CIN and DOM) and IS were extracted from plasma samples using the protein precipitation strategy. Chromatographic separation is accomplished by a C<sub>18</sub> Sunfire<sup>TM</sup> (5 µm, 250 mm × 4.6 mm) analytical column, using an isocratic mobile phase consisting of acetonitrile-methanol in 30:70 proportions at a flow rate of 1 mL/min. The detection of all three constituents was recorded at a wavelength of 270 nm with a UV detector. DOM, CIN and IS were eluted at 3.2, 4.5 and 6.1 min, respectively, utilizing a total run time of 10 min. The lower limit of quantification (LLOQ) was 5 ng/mL for CIN and DOM in rat plasma. The proposed RP-HPLC approach was linear in the 5–200 ng/mL range for CIN and DOM. The recovery of the method was greater than 95%, and the relative uncertainty was less than 2%, indicating that the proposed bioanalytical approach was accurate and precise. The limit of detection was established as 1.1 ng/mL for CIN and 1.7 ng/mL for DOM. The created approach was found to be robust and passed all validation criteria; thus, the proposed RP-HPLC approach can be employed successfully for the simultaneous assessment of CIN and DOM in rat plasma. |
| first_indexed | 2024-03-11T05:55:01Z |
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| language | English |
| last_indexed | 2024-03-11T05:55:01Z |
| publishDate | 2023-02-01 |
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| spelling | doaj.art-164b8f4864504307aebe1154be0c813d2023-11-17T13:49:52ZengMDPI AGSeparations2297-87392023-02-0110315910.3390/separations10030159RP-HPLC-Based Bioanalytical Approach for Simultaneous Quantitation of Cinnarizine and Domperidone in Rat PlasmaMohit Vij0Neha Dand1Lalit Kumar2Amardeep Ankalgi3Pankaj Wadhwa4Sultan Alshehri5Faiyaz Shakeel6Mohammed M. Ghoneim7Prawez Alam8Shahid Ud Din Wani9School of Pharmaceutical Sciences, Lovely Professional University, Phagwara 144411, Punjab, IndiaBharati Vidyapeeth’s College of Pharmacy, Navi Mumbai 400614, Maharashtra, IndiaSri Sai College of Pharmacy, Amritsar 143149, Punjab, IndiaLaureate Institute of Pharmacy, Kangra 176031, Himachal Pradesh, IndiaSchool of Pharmaceutical Sciences, Lovely Professional University, Phagwara 144411, Punjab, IndiaDepartment of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh 11451, Saudi ArabiaDepartment of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh 11451, Saudi ArabiaDepartment of Pharmacy Practice, College of Pharmacy, AlMaarefa University, Ad Diriyah 13713, Saudi ArabiaDepartment of Pharmacognosy, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Al-Kharj 11942, Saudi ArabiaDepartment of Pharmaceutical Sciences, School of Applied Science and Technology, University of Kashmir, Srinagar 190006, Jammu and Kashmir, IndiaAn accurate, precise and sensitive reverse-phase high-performance liquid chromatography (RP-HPLC) bioanalytical approach was developed for the simultaneous estimation of cinnarizine (CIN) and domperidone (DOM) in rat plasma using irbesartan (IRB) as an internal standard (IS). The proposed RP-HPLC approach was validated as per the latest ICH M10 guidelines. The analytes (CIN and DOM) and IS were extracted from plasma samples using the protein precipitation strategy. Chromatographic separation is accomplished by a C<sub>18</sub> Sunfire<sup>TM</sup> (5 µm, 250 mm × 4.6 mm) analytical column, using an isocratic mobile phase consisting of acetonitrile-methanol in 30:70 proportions at a flow rate of 1 mL/min. The detection of all three constituents was recorded at a wavelength of 270 nm with a UV detector. DOM, CIN and IS were eluted at 3.2, 4.5 and 6.1 min, respectively, utilizing a total run time of 10 min. The lower limit of quantification (LLOQ) was 5 ng/mL for CIN and DOM in rat plasma. The proposed RP-HPLC approach was linear in the 5–200 ng/mL range for CIN and DOM. The recovery of the method was greater than 95%, and the relative uncertainty was less than 2%, indicating that the proposed bioanalytical approach was accurate and precise. The limit of detection was established as 1.1 ng/mL for CIN and 1.7 ng/mL for DOM. The created approach was found to be robust and passed all validation criteria; thus, the proposed RP-HPLC approach can be employed successfully for the simultaneous assessment of CIN and DOM in rat plasma.https://www.mdpi.com/2297-8739/10/3/159bioanalytical method validationcinnarizinedomperidoneRP-HPLCrat plasma |
| spellingShingle | Mohit Vij Neha Dand Lalit Kumar Amardeep Ankalgi Pankaj Wadhwa Sultan Alshehri Faiyaz Shakeel Mohammed M. Ghoneim Prawez Alam Shahid Ud Din Wani RP-HPLC-Based Bioanalytical Approach for Simultaneous Quantitation of Cinnarizine and Domperidone in Rat Plasma Separations bioanalytical method validation cinnarizine domperidone RP-HPLC rat plasma |
| title | RP-HPLC-Based Bioanalytical Approach for Simultaneous Quantitation of Cinnarizine and Domperidone in Rat Plasma |
| title_full | RP-HPLC-Based Bioanalytical Approach for Simultaneous Quantitation of Cinnarizine and Domperidone in Rat Plasma |
| title_fullStr | RP-HPLC-Based Bioanalytical Approach for Simultaneous Quantitation of Cinnarizine and Domperidone in Rat Plasma |
| title_full_unstemmed | RP-HPLC-Based Bioanalytical Approach for Simultaneous Quantitation of Cinnarizine and Domperidone in Rat Plasma |
| title_short | RP-HPLC-Based Bioanalytical Approach for Simultaneous Quantitation of Cinnarizine and Domperidone in Rat Plasma |
| title_sort | rp hplc based bioanalytical approach for simultaneous quantitation of cinnarizine and domperidone in rat plasma |
| topic | bioanalytical method validation cinnarizine domperidone RP-HPLC rat plasma |
| url | https://www.mdpi.com/2297-8739/10/3/159 |
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