Drug

Name

System Suitability (n=6)

Precision of the Method b (n=3)

 

 

 

Parameter

Value

 

Actual Conc. (µg/mL)

Measured conc. (µg/mL),

% R.S.D

Intra-day

Inter-day

 

 

AT

Plates Count

15595

8

8.02,  1.08

8.03,  1.85

Symmetry a

1.06

16

16.08, 1.21

16.06, 1.68

% R.S.D.

0.87

24

24.17, 0.91

24.13, 1.23

 

 

EZ

Plates Count

15875

8

8.06,  0.95

7.90,  0.76

Resolution a

5.2

16

16.05, 1.80

16.12, 1.62

Symmetry a

1.10

24

24.19, 1.30

24.08, 1.05

% R.S.D.

1.42

FN

Plates Count

10304

128

128.80, 0.59

128.50, 1.31

Resolution a

9.9

256

257.10, 1.32

256.94, 1.73

Symmetry a

1.10

384

384.67, 0.79

384.98, 0.88

% R.S.D.

0.70






aUSP-NF 29 section 621, pp. 2135. bData expressed as mean for “measured concentration” Values
Table 1: System suitability parameters and results of precision.