Ph. Eur. Azithromycin - Related Substances peak identification solution injection on Gemini™ 3 µm NX-C18 150 x 4.6 mm using Waters® Arc HPLC system

LC Conditions

Official Method

Ph.Eur. M.1649

Column

Gemini 3 µm NX-C18 110 Å, LC Column 150 x 4.6 mm, Ea

Brand

Gemini

Part No

00F-4453-E0

Phase Name

NX-C18

Elution Type

Gradient

Mobile Phase

A: 1.80 g/L solution of anhydrous disodium hydrogen phosphate adjusted to pH 8.9

B: Acetonitrile:Methanol = 75:25

Gradient Profile

Step No.

Time(min)

%A

%B

1

0

50

50

2

9

45

55

3

10.8

40

60

4

28.8

25

75

5

29.16

50

50

6

33.48

50

50

Flow Rate

1.67 mL/min

Temperature

60°C

System

Waters Arc HPLC Waters HPLC System

Detection

LC/UV (DAD, PDA) @ 210 nm (nanometers)

Detection Info

Sample Notes

Diluent buffer: 1.73 g/L solution of ammonium dihydrogen pH adjusted to 10.0 with ammonia Diluent: Diluent buffer: Acetonitrile: methanol = 35:30:35 (v/v/v)