USP Rivaroxaban Assay and Organic Impurities - Sensitivity Solution run on run on Waters® AQUITY® H-Class

Analytes

1Rivaroxaban

Compound Name Rivaroxaban
CID 9875401
Molecular Formula C19H18ClN3O5S
Molecular Weight 435
No. Hydrogen Bond Acceptors 5
No. Hydrogen Bond Donors 1

Details

LC Conditions (App ID: 28029)

Column:

Luna Omega 3 µm C18 100 Å, LC Column 150 x 3.0 mm, Ea

Brand Name:

Luna Omega

Part No:

00F-4784-Y0

Phase Name:

C18

Elution Type:

Gradient

Mobile Phase:

A: Buffer(10mM potassium dihydrogen phosphate, 5.3mM sodium hexanesulfonate, 3.77mM phosphoric acid in water)/Methanol (95:5)

B: ACN

Gradient Profile:

Step No.	Time(min)	%A	%B
1	0	98	2
2	2.16	98	2
3	7.3	84	16
4	21.87	64	36
5	32.16	20	80
6	32.25	98	2
7	39	98	2

Flow Rate:

1 mL/min

Temperature:

60°C

System:

Waters ACQUITY UPLC H-Class Waters ACQUITY UPLC H-Class

Detection:

LC/UV (DAD, PDA) @ 250.0000000000 nm (nanometers)

Sample Note:

Solution B: 5.3mM sodium hexane sulfonate, 3.77mM phosphoric acid in water Diluent: Acetonitrile and solution B (40:60) Sensitivity solution: 0.25 µg/mL of USP Rivaroxaban RS in Diluent Peak no. 1 Analyte Name: sensitivity solution RT (min): 16.645 conc.: 0.25ug/mL

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