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Development and validation of HPLC method for quantification of docetaxel in palm-based nanoemulsion aerosols

Lung cancer is the leading cause of cancer-related deaths worldwide. Among the most potent of chemotherapeutic drugs used for lung cancer treatment are the taxanes, including docetaxel. However, the drugs’ efficacy in combating the disease is reduced due to their poor solubility, low stability and h...

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Main Authors: Asmawi, Azren Aida, Salim, Norazlinaliza, Abd Malek, Emilia, Abdul Rahman, Mohd Basyaruddin
Format: Article
Language:English
Published: Faculty of Science and Technology, Universiti Kebangsaan Malaysia 2020
Online Access:http://psasir.upm.edu.my/id/eprint/88418/1/ABSTRACT.pdf
http://psasir.upm.edu.my/id/eprint/88418/
https://mjas.analis.com.my/mjas/
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spelling my.upm.eprints.884182021-12-28T03:28:22Z http://psasir.upm.edu.my/id/eprint/88418/ Development and validation of HPLC method for quantification of docetaxel in palm-based nanoemulsion aerosols Asmawi, Azren Aida Salim, Norazlinaliza Abd Malek, Emilia Abdul Rahman, Mohd Basyaruddin Lung cancer is the leading cause of cancer-related deaths worldwide. Among the most potent of chemotherapeutic drugs used for lung cancer treatment are the taxanes, including docetaxel. However, the drugs’ efficacy in combating the disease is reduced due to their poor solubility, low stability and high toxicity. Inhalation therapy of lipid-based carrier has great potential in direct target towards the respiratory diseases. Hence, application of aerosolized palm-based nanoemulsion system is one approach to alleviate the drawbacks. This study describes the development and validation of method that can quantitate the amount of docetaxel nanoemulsion formulation via high-performance liquid chromatography (HPLC). Chromatographic analysis was conducted using a reversed phase C18 column with a mixture of acetonitrile and water (50:50) adjusted to pH 3.0 as the mobile phase. The flow rate was 1.0 mL/min and the detection was carried out by ultraviolet-visible detector at 228 nm. The developed method was validated in terms of specificity, linearity, accuracy and precision accordance with the International Conference on Harmonization (ICH) guidelines. The calibration curve was linear (r2= 0.999) over the concentration range from 62.5 to 1000 μg/mL with lower limit of detection (LOD) of 9.88 µg/mL and lower limit of quantification (LOQ) of 29.93 µg/mL. The percentage relative standard deviation for both intra and inter-day precision was less than 2%, while percentage recovery was more than 90%, indicating the precision and accuracy of the study. The developed HPLC method was proved as suitable and reliable for its intended application. Faculty of Science and Technology, Universiti Kebangsaan Malaysia 2020 Article PeerReviewed text en http://psasir.upm.edu.my/id/eprint/88418/1/ABSTRACT.pdf Asmawi, Azren Aida and Salim, Norazlinaliza and Abd Malek, Emilia and Abdul Rahman, Mohd Basyaruddin (2020) Development and validation of HPLC method for quantification of docetaxel in palm-based nanoemulsion aerosols. Malaysian Journal of Analytical Sciences, 24 (2). 165 - 172. ISSN 1394-2506 https://mjas.analis.com.my/mjas/
institution Universiti Putra Malaysia
building UPM Library
collection Institutional Repository
continent Asia
country Malaysia
content_provider Universiti Putra Malaysia
content_source UPM Institutional Repository
url_provider http://psasir.upm.edu.my/
language English
description Lung cancer is the leading cause of cancer-related deaths worldwide. Among the most potent of chemotherapeutic drugs used for lung cancer treatment are the taxanes, including docetaxel. However, the drugs’ efficacy in combating the disease is reduced due to their poor solubility, low stability and high toxicity. Inhalation therapy of lipid-based carrier has great potential in direct target towards the respiratory diseases. Hence, application of aerosolized palm-based nanoemulsion system is one approach to alleviate the drawbacks. This study describes the development and validation of method that can quantitate the amount of docetaxel nanoemulsion formulation via high-performance liquid chromatography (HPLC). Chromatographic analysis was conducted using a reversed phase C18 column with a mixture of acetonitrile and water (50:50) adjusted to pH 3.0 as the mobile phase. The flow rate was 1.0 mL/min and the detection was carried out by ultraviolet-visible detector at 228 nm. The developed method was validated in terms of specificity, linearity, accuracy and precision accordance with the International Conference on Harmonization (ICH) guidelines. The calibration curve was linear (r2= 0.999) over the concentration range from 62.5 to 1000 μg/mL with lower limit of detection (LOD) of 9.88 µg/mL and lower limit of quantification (LOQ) of 29.93 µg/mL. The percentage relative standard deviation for both intra and inter-day precision was less than 2%, while percentage recovery was more than 90%, indicating the precision and accuracy of the study. The developed HPLC method was proved as suitable and reliable for its intended application.
format Article
author Asmawi, Azren Aida
Salim, Norazlinaliza
Abd Malek, Emilia
Abdul Rahman, Mohd Basyaruddin
spellingShingle Asmawi, Azren Aida
Salim, Norazlinaliza
Abd Malek, Emilia
Abdul Rahman, Mohd Basyaruddin
Development and validation of HPLC method for quantification of docetaxel in palm-based nanoemulsion aerosols
author_facet Asmawi, Azren Aida
Salim, Norazlinaliza
Abd Malek, Emilia
Abdul Rahman, Mohd Basyaruddin
author_sort Asmawi, Azren Aida
title Development and validation of HPLC method for quantification of docetaxel in palm-based nanoemulsion aerosols
title_short Development and validation of HPLC method for quantification of docetaxel in palm-based nanoemulsion aerosols
title_full Development and validation of HPLC method for quantification of docetaxel in palm-based nanoemulsion aerosols
title_fullStr Development and validation of HPLC method for quantification of docetaxel in palm-based nanoemulsion aerosols
title_full_unstemmed Development and validation of HPLC method for quantification of docetaxel in palm-based nanoemulsion aerosols
title_sort development and validation of hplc method for quantification of docetaxel in palm-based nanoemulsion aerosols
publisher Faculty of Science and Technology, Universiti Kebangsaan Malaysia
publishDate 2020
url http://psasir.upm.edu.my/id/eprint/88418/1/ABSTRACT.pdf
http://psasir.upm.edu.my/id/eprint/88418/
https://mjas.analis.com.my/mjas/
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score 13.222552

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