Quantitative Determination of α-Tocopherol and α-Tocopheryl Acetate in Pharmaceutical and Supplementary Soft Capsules by High Performance Liquid Chromatography

Yıl 2025, Sayı: 26, 500 - 511, 31.08.2025

Nükte Topraksever , Gamze Özgül Artuç

https://doi.org/10.38079/igusabder.1589685

Öz

Aim: This study aims to determine the amounts of α-tocopherol (α-toc) and α-tocopheryl acetate (α-tocAc) in soft pharmaceutical capsules and supplements using a chromatographic method. Additionally, method validation parameters for both analytes were evaluated.
Method: Analyses were performed using a chromatographic method. As part of the method validation, recovery (% recovery), repeatability (% RSD), linear regression coefficient (R²), limit of detection (LOD), and limit of quantification (LOQ) values were determined.
Results: The recovery values were found to be above 95%. Repeatability (%RSD) was calculated as <3%. The linearity (R²) values were obtained as 0.999. For α-toc: LOD: 0.131 µg/mL and 2.228 µg/mL, LOQ: 0.396 µg/mL and 6.752 µg/mL. For α-tocAc: LOD: 0.260 µg/mL, LOQ: 0.787 µg/mL.
Conclusion: The chromatographic method used in this study enabled the determination of α-toc and α-tocAc with high accuracy and repeatability. This method can be considered a reliable alternative for the analysis of these compounds in pharmaceutical products.

Anahtar Kelimeler

α-tocopherol , α-tocopheryl acetate , HPLC , soft capsule

Farmasötik ve Takviye Edici Yumuşak Kapsüllerdeki α-Tokoferol ve α-Tokoferil Asetat’ın Yüksek Performanslı Sıvı Kromatografisi ile Kantitatif Tayini

Öz

Amaç: Bu çalışmada, yumuşak farmasötik kapsüller ve takviyelerde bulunan α-tokoferol (α-tok) ve α-tokoferil asetat (α-tokAs) miktarlarının kromatografik yöntem kullanılarak belirlenmesi amaçlanmıştır. Ayrıca, her iki analit için yöntem doğrulama (validasyon) parametreleri değerlendirilmiştir.
Yöntem: Analizler kromatografik bir yöntemle gerçekleştirilmiştir. Yöntem validasyonu kapsamında geri kazanım, tekrarlanabilirlik, doğrusal regresyon katsayısı, LOD ve LOQ değerleri belirlenmiştir.
Bulgular: Geri kazanım değerleri %95’in üzerinde bulunmuştur. Tekrarlanabilirlik (%RSD) <%3 olarak hesaplanmıştır. Doğrusallık (R²) değerleri 0.999 olarak elde edilmiştir. α-tok için: LOD: 0.131 µg/mL ve 2.228 µg/mL, LOQ: 0.396 µg/mL ve 6.752 µg/mL α-tokAs için: LOD: 0.260 µg/mL, LOQ: 0.787 µg/mL.
Sonuç: Çalışmada kullanılan kromatografik yöntem, α-tok ve α-tokAs miktarlarının yüksek doğruluk ve tekrarlanabilirlik ile belirlenmesini sağlamıştır. Yöntem, farmasötik ürünlerdeki bu bileşiklerin analizi için güvenilir bir alternatif olarak değerlendirilebilir.

Anahtar Kelimeler

α-tokoferol , α-tokoferil asetat , HPLC , yumuşak kapsül

Kaynakça

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