System suitability parameters

Observation

Acceptance criteria

Tailing factor for amlodipine peak in diluted standard preparation

1.0

Not more than 2.0

Plate count for amlodipine peak

43,685

Not less than 2000

% RSD for areas of amlodipine

3.2

Not more than 3.0

Resolution between Imp-B and Imp-H

2.7

Not less than 2.0