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

Abstract

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.

Keywords

• 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

Abstract

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.

Keywords

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

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