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268nm,4nm (1.00)
Impurity Analysis of Antacid Tablets
Famotidine and Recognized Impurities
using the
USP Method
on
Allure C18 5µm 4.6 x 250 mm column
1 – Impurity A
2 – Impurity B
3 – Impurity C
4 – Famotidine
5 – Impurity D
1
2 3
4
5
Instrument:
Shimadzu
Prominence UFLC
XR
(9500psi)
Sample:
Inj.: 10µL
Conc.: 100 µg/mL
10 µg/mL each impurity
Sample Diluent: Methanol
Mobile Phase:
A: 93:7
100mM sodium citrate
trihydrate in water (pH 6.0 with
glacial acetic acid):
Acetonitrile
B: Acetonitrile
Time:
%B
0min
0%
15min
0%
42min
48%
43min
0%
45min
0%
Flow: 1.5 mL/min
Temp.: 35°C
Det.: UV @ 268 nm
• Way too long
• Concentrated buffer
• pH 6 shows RT shifts
• ACN mobile phase
33
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