Page 4 - Shimadzu i-Series Method Transfer System

Dual Flow Lines Simplify the Process

of Migrating Methods

A single integrated system allows analyses in two flow lines with UHPLC and HPLC delay volumes. In addition to
simplifying the transfer of analytical methods for customers using HPLC, it can also streamline the process of
converting customers’ analytical methods from HPLC to higher-speed UHPLC.

Supports Method Compatibility Compliant with

the United States Pharmacopeia

General Chapter <621> Chromatography in the United States Pharmacopeia specifies allowable ranges for changes to
analytical parameters, so that revalidation is not necessary as long as the setting values remain within those allowable
ranges. i-Series MT system includes dual flow lines for HPLC and UHPLC analysis. With two system volumes, it can
support both existing analytical methods and UHPLC methods.

Flow line 1
HPLC Conditions
mAU
Column : Shim-pack™ VP-ODS 2.25
150 mm L. × 4.6 mm I.D., 5.0 µm
2.00
Mobile phase A : Phosphate (potassium) buffer
solution, pH 3.5 1.75 Ketoprofen (82.43%)
Mobile phase B : Acetonitrile 1.50 Impurity C (9.98%)
Composition : A/B = 57/43 (v/v) 1.25 Impurity B (5.22%)
Flow rate : 1.0 mL/min 1.00 Impurity A (2.37%)
Column temperature : 40°C 0.75
Injection volume : 20 µL 0.50
Sample : Ketoprofen 1 mg/mL 0.25
0.00
0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 10.0 11.0 12.0 min

Flow line 2
UHPLC Conditions 10 mAU
Column : Shim-pack XR-ODS II 9
75 mm L. × 3.0 mm I.D., 2.2 µm 8
Mobile phase A : Phosphate (potassium) buffer 7
solution, pH 3.5 6 Ketoprofen (81.71%)
Mobile phase B : Acetonitrile Impurity C (10.24%)
5
Composition : A/B = 57/43 (v/v)
4 Impurity B (5.60%)
Flow rate : 1.0 mL/min Impurity A (2.44%)
3
Column temperature : 40°C
2
Injection volume : 20 µL
1
Sample : Ketoprofen 1 mg/mL
0
0.00 0.25 0.50 0.75 1.00 1.25 1.50 1.75 2.00 2.25 2.50 2.75 min

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