Malaysian Journal of Analytical Sciences Vol 24 No 2 (2020): 165 - 172

 

 

 

 

DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR QUANTIFICATION OF DOCETAXEL IN PALM-BASED NANOEMULSION AEROSOLS

 

(Pembangunan dan Validasi Kaedah KCPT untuk Kuantifikasi Docetaxel di dalam Nanoemulsi Aerosol Berasaskan Sawit)

 

Azren Aida Asmawi¹, Norazlinaliza Salim^1,2, Emilia Abdulmalek^1,2, Mohd Basyaruddin Abdul Rahman^1,2*

 

¹Integrated Chemical BioPhysics Research, Faculty of Science

²Department of Chemistry, Faculty of Science

Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia

 

*Corresponding author: basya@upm.edu.my

 

 

Received: 20 November 2019; Accepted: 3 March 2020

 

 

Abstract

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.

 

Keywords:  aerosols, docetaxel, high-performance liquid chromatography, nanoemulsion, lung cancer

 

Abstrak

Kanser paru-paru adalah punca utama kematian akibat kanser di seluruh dunia. Antara ubat kemoterapi yang berkesan digunakan untuk rawatan kanser paru-paru ialah taxane, termasuk docetaxel. Walau bagaimanapun, keberkesanan ubat dalam merawati penyakit ini berkurangan disebabkan oleh kelarutannya yang kurang baik, kestabilan yang rendah dan ketoksikan yang tinggi. Oleh itu, penggunaan sistem nanoemulsi berasaskan sawit adalah satu pendekatan untuk mengurangkan kelemahan tersebut. Kajian ini menerangkan pembangunan dan validasi yang boleh mengkuantifikasi jumlah docetaxel di dalam rumusan nanoemulsi melalui kaedah kromatografi cecair prestasi tinggi (KCPT). Analisis kromatografi dijalankan menggunakan turus fasa terbalik C₁₈ dengan campuran asetonitril dan air (50:50) diselaraskan kepada pH 3.0 sebagai fasa bergerak. Kadar aliran adalah 1.0 mL/min dan pengesanan dilakukan oleh pengesan ultralembayung-nampak pada 228 nm. Kaedah yang dibangunkan telah disahkan dari segi kekhususan, kelinearan, kejituan, ketepatan dan kepersisan berdasarkan garis panduan persidangan pengharmonian antarabangsa (ICH). Plot tentukuran adalah linear (r² = 0.999) di atas kepekatan antara 62.5 hingga 1000 μg/mL dengan had pengesanan (LOD) iaitu 9.88 μg/mL dan had kuantifikasi (LOQ) sebanyak 29.93 μg/mL. Peratusan sisihan piawai relatif  untuk kedua-dua kepersisan intra dan inter-hari adalah kurang daripada 2%, manakala purata kejituan adalah lebih daripada 90%, menunjukkan kepersisan dan ketepatan kajian. Kaedah KCPT yang dibangunkan terbukti sesuai dan boleh digunakan untuk aplikasi yang dirancangkan.

 

Kata kunci:  aerosol, docetaxel, kromatografi cecair prestasi tinggi, nanoemulsi, kanser paru-paru

 

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