| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 1203367 | Journal of Chromatography A | 2011 | 8 Pages |
A simple and direct reversed-phase high performance liquid chromatography (RP-HPLC) method with UV detection was developed and validated for the determination of mono- and di-d-α-tocopherol polyethylene glycol 1000 succinate (TPGS 1000) in TPGS mixture. Before the HPLC analysis, mono- and di-TPGS 1000 were separated by simulated moving bed (SMB) chromatography system and characterized by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS). The mass spectrometric results confirmed that the molar mass distribution of TPGS prepared in our laboratory was very close to that of the product of Eastman Chemical Company with similar n¯ (average polymerization degree), Mn¯ (number-average molecular weight) and Mw¯ (weight-average molecular weight). The HPLC analysis was carried out on a C30 analytical column with mobile phases comprised of acetonitrile (A) and isopropanol (B) in gradient conditions. Validation of the analytical method was done on the following parameters: system suitability, linearity, limits of detection and quantification, accuracy and precision, method robustness and solution stability. The linearity of the calibration curves for mono- and di-TPGS 1000 from both sources was found to be good (r2 > 0.9996). The recovery values were from 94.6% to 103.3% for mono-TPGS, and 93.5% to 103.3% for di-TPGS. This method could be successfully used in the direct quantification of mono- and di-TPGS in TPGS 1000 mixture using TPGS standards with similar molecular mass distributions although derived from different sources.
► Mono- and di-TPGS are quantified by a simple and direct HPLC method. ► Standards of them are prepared by SMB and characterized by MALDI-TOF MS. ► The method can be used even the molar mass distributions were not in complete accord. ► The method is accurate, precise and robust. ► The method can be successfully used in the quantification of them in TPGS mixtures.
