Page 48 - Pharmaceutical Solution for Pharma Analysis

LAAN-A-LC-E266

Application High Performance Liquid Chromatography

News Analysis of Mannitol Using RID-20A Differential

Index Detector
No.L489

Mannitol possesses characteristics that include low
moisture absorption and low reactivity, and is therefore
used as an excipient for pharmaceuticals. USP methods
for D-mannitol (hereafter, "mannitol") were amended
in 2014 to specify the use of refractive index detection
with a 7.8 mm × 300 mm L19 column.
The RID-20A differential refractive index detector
features an optical system with dual temperature
control to absorb the impact of subtle changes in Fig. 1 Structure of D-Mannitol
temperature, thereby permitting chromatograms to be
generated with a stable baseline. Here, we introduce an
example of mannitol analysis using the RID-20A.

uRIU
20.0
17.5 ■ Peaks
n System Suitability 15.0 2 1. Isomalt (1)
12.5 2. Maltitol
Fig. 1 shows the structural formula of mannitol. The 10.0 3. Isomalt (2)
test method for mannitol specifies that two types of 7.5 1 3 4. Mannitol
system suitability test standard solutions be analyzed. 5.0 5. Sorbitol
The upper data of Fig. 2 shows the system suitability 2.5
test results for Standard Solution 1, consisting of 0.0
isomalt and maltitol standards (each 1 g/L), and the 0.0 2.5 5.0 7.5 10.0 12.5 15.0 17.5 20.0 22.5 25.0 27.5 min
uRIU
lower data of Fig. 2 shows the results using Standard 400
350
Solution 2, consisting of mannitol and sorbitol 300 4
standards (each 25 g/L). Table 1 shows the analytical 250 5
conditions. 200
Table 2 shows the reference values for the system 150
suitability test, in addition to the analysis results. The 100
50
results confirm that system suitability is satisfied with 0
respect to all the criteria. 0.0 2.5 5.0 7.5 10.0 12.5 15.0 17.5 20.0 22.5 25.0 27.5 min
Fig. 2 Chromatograms of a Standard Mixture of Four Sugar Alcohols
Table 1 Analytical Conditions
Upper: System Suitability Solution 1 (Isomalt, Maltitol)
Lower: System Suitability Solution 2 (Mannitol, Sorbitol)
System : Prominence
Column : Shim-pack SCR-101C
(300 mm L. × 7.9 mm I.D., 10 μm)
Mobile Phase : Water
Flowrate : 0.5 mL/min
Column Temp. : 85 ˚C
Injection Volume : 20 μL
Detection : RID-20A
Table 2 Results of System Suitability Test
System Suitability Target Reference Value Analysis
Assessment Item Substance Result
Approximately 20 20.9
Retention Time Mannitol
minutes minutes
Isomalt (1) Approximately 0.6 0.68
Relative Retention Maltitol Approximately 0.69 0.73
Time with Respect
to Mannitol Isomalt (2) Approximately 0.73 0.76
Sorbitol Approximately 0.12 1.2
Mannitol and
Resolution Greater than 2.0 5.0
sorbitol
Relative Standard
Deviation of Peak Mannitol Less than 1.0 % 0.03 ％
Area Value