USP Rivaroxaban Assay and Organic Impurities - System Suitability Solution run on Agilent® 1260

LC Conditions

Column

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

Brand

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

1.22

98

2

3

6.36

84

16

4

20.93

64

36

5

31.22

20

80

6

31.3

98

2

7

38.3

98

2

Flow Rate

1.00 mL/min

Temperature

60°C

System

Agilent Technologies 1200 Series Agilent Technologies 1200 Series

Detection

LC/UV (DAD, PDA) @ 250 nm (nanometers)

Detection Info

Sample Notes

Solution B: 5.3mM sodium hexane sulfonate, 3.77mM phosphoric acid in water Diluent: Acetonitrile and solution B (40:60) System suitability solution: 0.5 mg/mL of USP Rivaroxaban RS and 0.5 µg/mL each of USP Rivaroxaban Related Compound B RS, USP Rivaroxaban Related Compound D RS, USP Rivaroxaban Related Compound G RS, and USP Rivaroxaban Related Compound J RS in Diluent​ peak no. 1 analyte name: rivaroxaban related compound G RT (min): 14.099 conc.: 0.5ug/mL peak no. 2 analyte name: rivaroxaban RT (min): 15.66 conc.: 0.5mg/mL