| Autor: |
Vijakumaran Ubashini, Kouhsari Ebrahim, Mazumder Rupa, F. Al Marjania Mohammed, Azarkan Mohamed, Bisth Shradha, Kaplan Ozan, Kumar Das Sumon, Liu Jiang, Gee Jun Tye, Abdul Hamid Zariyantey, Habib Jibona Rayhan, Chen Lexing, Calvo Esposito Rafaèle, Nordin Fazlina, Marta González Mariana, Bellal Hossain, H. Authman Sawsan, Priya S. Sathya, Jiang Zhounan, Mohapatra Hitesh, Abdullah Maha, Celebier Mustafa, Li Shiying, Al-Mamun Bulbul Abdullah, Gan Xia, Roy Tonmoy, Cai Shaohui, M.K. Sandhya, Izat Nihan, Xu Jun, Eugenia Errasti María, Kumar Rath Amiya, Sahin Selma, Avijit Saha Md., S. Ali Fatima, Padhi Swarupanjali |
| Rok vydání: |
2021 |
| Předmět: |
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| Zdroj: |
Current Pharmaceutical Analysis. 17:919-925 |
| ISSN: |
1573-4129 |
| Popis: |
Background: The number of validated quantification methods for rifampicin, a prototypical Oatp inhibitor, in biological rat samples was limited. Objective: This study was conducted to validate a modified reversed-phase liquid chromatographic method for the determination of rifampicin in rat liver tissue according to the current ICH M10 Bioanalytical Method Validation Draft Guideline (2019) for application to samples of in situ rat liver perfusion studies. Methods: Liver tissue samples were obtained from recirculatory in situ rat liver perfusion studies. The analysis was performed on a C18 column with a mobile phase composed of 0.05 M phosphate buffer (pH 4.58): acetonitrile (55:45, v/v). The assay was validated for selectivity, calibration curve and range, matrix effect, carry-over, accuracy and precision, reinjection reproducibility, and stability. Results: he method was considered selective and stable, without having carry-over and matrix effects. The calibration curve was linear (R2: 0.9983) within the calibration range (0.5-60 ppm). Accuracy and precision values fulfilled the required limits. Liver concentrations of rifampicin in liver tissue, obtained after 60 min perfusion with 10 μM and 50 μM of rifampicin, were 45.1 ± 11.2 and 313.4 ± 84.4 μM, respectively. Conclusion: The bioanalytical method validation was completed and the method was successfully applied for the determination of rifampicin in rat liver tissue. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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