Enantiomeric Separation and Quantitation of Tenofovir Disoproxil Fumarate Using Amylose-Based Chiral Stationary Phases by High-Performance Liquid Chromatography

• Autorzy: Heydari R. , Shamsipur M.
• Języki publikacji: EN

Abstrakty

EN

A rapid high-performance liquid chromatography (HPLC) method for chiral purity determination of tenofovir disoproxil fumarate in raw material and pharmaceutical formulations was developed. The (S)-enantiomer appears to be as an impurity and pharmacologically inactive. The effects of various stationary phases, mobile phase composition, and column temperature on enantiomeric separation of tenofovir disoproxil were investigated and optimized. Chromatography resolution of tenofovir disoproxil enantiomers was performed on NUCLEOCEL ALPHA-RP S column (250 × 4.6 mm i.d., 5 μm). The elution was achieved by using 95:5% (υ/υ) methanol—acetonitrile, containing 0.1% triethylamine at a flow rate of 0.8 mL min−1. The ultraviolet (UV) detector was set at 260 nm. Calibration curves were linear in the range of 1–100 μg mL−1 and 0.2–20 μg mL−1 for (R)-tenofovir disoproxil and (S)-enantiomer, respectively. Limits of detection and quantitation for (S)-enantiomer were 0.06 and 0.2 μg mL−1. The run time of analysis was less than 7.0 min. The proposed method was used successfully for separation and quantification of tenofovir disoproxil enantiomers in raw material and pharmaceutical formulations.

Słowa kluczowe

EN

tenofovir disoproxil fumarate; NUCLEOCEL ALPHA-RP S column; enantiomeric; separation; high-performance liquid chromatography

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2015
• Tom: Vol. 27, no. 4
• Strony: 583--595
• Opis fizyczny: Bibliogr. 22 poz., rys., tab.

Twórcy

autor

Heydari R.

• Razi Herbal Medicines Research Center, Lorestan University of Medical Sciences, P.O. Box 68149-89468, Khorramabad, Iran

autor

Shamsipur M.

• Department of Chemistry, Razi University, Kermanshah, Iran

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