Bioanalytical method validation for determination of rosmarinic acid in simulated biological media using hplc
Objective: This study aims to develop and validate a simple, rapid and accurate HPLC method for the determination of rosmarinic acid (RA), an active marker of Thunbergia laurifolia (TL) tea, in Hank's Balanced Salt Solution (HBSS) using HPLC. Methods: The separation was performed using a Xterra...
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th-mahidol.789802022-08-04T18:24:35Z Bioanalytical method validation for determination of rosmarinic acid in simulated biological media using hplc Kotchaphan Chooluck Piyanuch Rojsanga Chutima Phechkrajang Montree Jaturanpinyo Mahidol University Pharmacology, Toxicology and Pharmaceutics Objective: This study aims to develop and validate a simple, rapid and accurate HPLC method for the determination of rosmarinic acid (RA), an active marker of Thunbergia laurifolia (TL) tea, in Hank's Balanced Salt Solution (HBSS) using HPLC. Methods: The separation was performed using a Xterra® C 18 reversed-phase column (150 × 3.9 mm, 5 µm). The mobile phase consisted of 0.5% (v/v) glacial acetic acid (A) and acetonitrile (B). The flow rate was 1 ml/min and detection was carried out at 330 nm with UV-visible spectrophotometer. The method was validated according to the US FDA guidance on bioanalytical method validation in 2018. Results: The method was successfully validated in the range of 50-500 ng/ml of RA. Intra-and inter-day precision ranged from 1.6 to 2.1% and 1.4 to 4.5%, respectively. Intra-and inter-day relative errors (% bias) were less than 7.6 and 3.6%, respectively. In addition, it was found that the stability of RA in HBSS could be dependent on the pH and temperature. Conclusion: The developed method met the validation requirements and could be further applied to the permeability study of RA using an in vitro Caco-2 cell monolayer model. 2022-08-04T11:24:35Z 2022-08-04T11:24:35Z 2021-01-01 Article International Journal of Applied Pharmaceutics. Vol.13, No.2 (2021), 110-113 10.22159/ijap.2021v13i2.40372 09757058 2-s2.0-85103288181 https://repository.li.mahidol.ac.th/handle/123456789/78980 Mahidol University SCOPUS https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85103288181&origin=inward |
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Pharmacology, Toxicology and Pharmaceutics Kotchaphan Chooluck Piyanuch Rojsanga Chutima Phechkrajang Montree Jaturanpinyo Bioanalytical method validation for determination of rosmarinic acid in simulated biological media using hplc |
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Objective: This study aims to develop and validate a simple, rapid and accurate HPLC method for the determination of rosmarinic acid (RA), an active marker of Thunbergia laurifolia (TL) tea, in Hank's Balanced Salt Solution (HBSS) using HPLC. Methods: The separation was performed using a Xterra® C 18 reversed-phase column (150 × 3.9 mm, 5 µm). The mobile phase consisted of 0.5% (v/v) glacial acetic acid (A) and acetonitrile (B). The flow rate was 1 ml/min and detection was carried out at 330 nm with UV-visible spectrophotometer. The method was validated according to the US FDA guidance on bioanalytical method validation in 2018. Results: The method was successfully validated in the range of 50-500 ng/ml of RA. Intra-and inter-day precision ranged from 1.6 to 2.1% and 1.4 to 4.5%, respectively. Intra-and inter-day relative errors (% bias) were less than 7.6 and 3.6%, respectively. In addition, it was found that the stability of RA in HBSS could be dependent on the pH and temperature. Conclusion: The developed method met the validation requirements and could be further applied to the permeability study of RA using an in vitro Caco-2 cell monolayer model. |
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Mahidol University |
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Mahidol University Kotchaphan Chooluck Piyanuch Rojsanga Chutima Phechkrajang Montree Jaturanpinyo |
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Article |
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Kotchaphan Chooluck Piyanuch Rojsanga Chutima Phechkrajang Montree Jaturanpinyo |
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Kotchaphan Chooluck |
title |
Bioanalytical method validation for determination of rosmarinic acid in simulated biological media using hplc |
title_short |
Bioanalytical method validation for determination of rosmarinic acid in simulated biological media using hplc |
title_full |
Bioanalytical method validation for determination of rosmarinic acid in simulated biological media using hplc |
title_fullStr |
Bioanalytical method validation for determination of rosmarinic acid in simulated biological media using hplc |
title_full_unstemmed |
Bioanalytical method validation for determination of rosmarinic acid in simulated biological media using hplc |
title_sort |
bioanalytical method validation for determination of rosmarinic acid in simulated biological media using hplc |
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2022 |
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https://repository.li.mahidol.ac.th/handle/123456789/78980 |
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1763489494257893376 |