Documentation

Method Abstract 327

MA 327 / ANALYSIS OF VOGLIBOSE IN PHARMACEUTICAL FORMULATIONS

BY HPLC WITH POST-COLUMN DERIVATIZATION

Voglibose is an Alpha-Glucosidase inhibitor widely used for the treatment of diabetes. Alpha-Glucosidase inhibitors are agents that delay the glucose absorption at the intestinal level and thereby prevent sudden surge of glucose after a meal. Vogilbose is the safest and most effective drug of its class.

Since Vogibose has no UV chromophore, post-column derivatization is employed to produce a fluorescent derivative.

This abstract describes a very sensitive and robust analytical method for the analysis of Voglibose in pharmaceutical tablets. Simple sample preparation and fast analysis time allow for using this method in high throughput environments.
 

METHOD

Analytical Conditions

Column: Amino column, 4.6×250 mm
Temperature: 35 °C
Flow Rate: 0.6 mL/min
Mobile Phase: Sodium phosphate buffer, 20 mM
       pH 6.5 / Acetonitrile (37 : 63)
Injection Volume: 50 μL

Sample Preparation

Crush 5 tablets and mix with 25 mL of mobile phase. Sonicate for 10 min and filter liquid portion through
0.45 μm filter. Put in HPLC autosampler vial and inject 50 μL.

Post-column Conditions

Post-column System: Pinnacle PCX
Heated Reactor Volume: 3.5 mL
Temperature: 100 °C
Cooling Coil: 0.15 mL (at room temperature)
Reagent: Taurine (6.25 g), Sodium Periodate (2.56 g) in 1000 mL of water
Flow Rate: 0.6 mL/min
Detection: FLD
                 λex: 350 nm, λem: 430 nm


Repeatability studies for different concentration levels.

 

0.5 ppm

100 ppm

Average RT, min

21.25

21.26

RSD, %, N = 6

0.36

0.08

Average Peak Area

9.22

1,562.69

RSD, %, N = 6

1.48

0.79


chart-m-327


chart-m-327b


chart-m-327c


chart-m-327d