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

Heydari, R. and Shamsipur, M (2015) Enantiomeric Separation and Quantitation of Tenofovir Disoproxil Fumarate Using Amylose-Based Chiral Stationary Phases by High-Performance Liquid Chromatography. ACTA CHROMATOGRAPHICA, 28 (4). pp. 583-595. ISSN 1233-2356

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Abstract

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 x 4.6 mm i.d., 5 mu m). The elution was achieved by using 95:5% (v/v) 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 mu g mL(-1) and 0.2-20 mu g mL(-1) for (R)-tenofovir disoproxil and (S)-enantiomer, respectively. Limits of detection and quantitation for (S)-enantiomer were 0.06 and 0.2 mu g 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.

Item Type: Article
Subjects: A General Works > AM Museums (General). Collectors and collecting (General)
Depositing User: sobhan rezaiian
Date Deposited: 23 Oct 2017 12:03
Last Modified: 23 Oct 2017 12:03
URI: http://eprints.lums.ac.ir/id/eprint/674

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