Sildenafil Citrate RS and Sildenafil N-Oxide USP System Suitability Solution on Luna Omega 5 µm C18 150x4.6mm LC/UV

LC Conditions

Column

Luna Omega 5 µm C18 100 Å, LC Column 150 x 4.6 mm, Ea

Brand

Luna Omega

Part No

00F-4785-E0

Phase Name

C18

Elution Type

Isocratic

Mobile Phase

A: Buffer (dilute 7 mL of triethylamine with water to 1 L. Stir and adjust with phosphoric acid to a pH of 3.0+/- 0.1), Methanol and Acetonitrile (58:25:17)

Gradient Profile

Step No.

Time(min)

%A

%B

1

20

100

Flow Rate

1.40 mL/min

Temperature

30°C

System

Agilent Technologies 1100 Series Agilent Technologies 1100 Series

Detection

LC/UV (DAD, PDA) @ 290 nm (nanometers) (30°C)

Detection Info

Sample Notes

Dissolve 70 mg of Sildenafil Citrate in 1 mL of a solution of hydrogen peroxide and anhydrous formic acid (2:1). Allow to stand for at least 10 minutes to generate Sildenafil N-Oxide, then dilute w/mobile phase to 250 mL.