Analysis of Voglibose According to JP Method (NH2P-50 4E)

According to the Japanese Pharmacopoeia (JP XVII*), "(2) Related substances" for “Voglibose" should be carried out with a column filled with pentaethylenehexaaminated polyvinyl alcohol polymer bead. The Asahipak NH2P-50 4E confirmed the requirements were met.

 

（Note）

This analysis requires column equilibration.
For column equilibration: First introduce 100 mM Sodium phosphate buffer (pH6.5) at 0.5 mL/min for 2 hours, and then switch to the eluent at 0.5 mL/min for 2 hours.

System suitability requirementsPeak area of voglibose (10-fold diluted Standard solution): 7 - 13% of the peak area of voglibose in the Standard solution.
Theoretical plate number of voglibose peak (Standard solution): ≥ 7,000
Symmetry factor of voglibose peak (Standard solution): 0.8 - 1.2
Relative standard deviation (RSD) of the peak area of voglibosel (Standard solution): ≤ 3.0% (repeated 6 times)

*The version at the time of the application acquisition.

Sample: 50 µL
(Standard solution) 10 μg/mL of Voglibose in eluent

  1. 1.Voglibose
Column
：Shodex Asahipak NH2P-50 4E (4.6 mm I.D. x 250 mm)
Eluent
：20 mM Sodium phosphate buffer (pH6.5)/CH3CN=37/63
Reagent
：12 mM NaIO4 + 50 mM Taurine aq.
Flow rate
：(Eluent) 0.6 mL/min, (Reagent) 0.5 mL/min
Detector
：Fluoresence (Ex. 350 nm, Em. 430 nm) (post-column reaction)
Column temp.
：25 ℃
Reaction temp.
：100 ℃
Cooling temp.
：15 ℃

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