Title and chromatogram

Title Related Compound analysis of Lactulose as per USP monograph

Sodium Lactate standard Chromatogram

1
 Procedure

Description The Thermo Scientific Dionex UltiMate 3000 LC system is applied

for the analysis of Lactulose. The separation was performed on a
Thermo Scientific Hypersil Gold amino HPLC column.

The results obtained for RRT and Resolution exceeded the

criteria stated in the USP monograph. The results obtained are as
follows:
USP acceptance
Sr. No. Parameter Obtained Results
criteria
Relative retention time for Epilactose
1 0.85 min 0.92 min
with respect to Lactulose peak

Relative retention time for Lactose with

2 1.1 min 1.22 min
respect to Lactulose peak

Resolution between Epilactose and

3 NLT 0.9 1.28
Lactose Peak

Resolution between Lactulose and

4 NLT 1.5 3.17
Lactose Peak