|
Modification in chromatographic conditions
|
Retention time (min)
|
Plate count
|
Tailing factor
|
% RSD
|
Reso
|
Retention time from sample
|
|---|
|
TLS
|
RST
|
TLS
|
RST
|
TLS
|
RST
|
TLS
|
RST
|
TLS
|
RST
|
|---|
|
As per method
|
2.553
|
4.505
|
2917
|
8288
|
1.44
|
1.23
|
1.67
|
1.52
|
9.40
|
2.548
|
4.493
|
|
Flow rate − 0.1 mL/min
|
2.974
|
4.919
|
2804
|
8564
|
1.41
|
1.24
|
0.46
|
0.76
|
8.55
|
2.856
|
4.974
|
|
Flow rate + 0.1 mL/min
|
2.326
|
4.075
|
2746
|
7911
|
1.38
|
1.22
|
0.54
|
0.65
|
9.11
|
2.322
|
4.076
|
|
Organic phase − 10%
|
2.737
|
5.299
|
3226
|
8411
|
1.50
|
1.25
|
0.59
|
1.06
|
11.41
|
2.599
|
5.352
|
|
Organic phase + 10%
|
2.096
|
3.944
|
2986
|
6733
|
1.41
|
1.22
|
0.73
|
0.85
|
10.15
|
2.057
|
3.915
|
|
Buffer phase − 10%
|
2.095
|
4.047
|
2536
|
7191
|
1.48
|
1.22
|
0.51
|
0.58
|
10.93
|
2.108
|
4.000
|
|
Buffer phase + 10%
|
2.722
|
5.219
|
3070
|
9911
|
1.40
|
1.19
|
0.54
|
0.70
|
11.65
|
2.575
|
5.313
|
|
pH of buffer − 0.2
|
2.041
|
4.435
|
2762
|
8118
|
1.30
|
1.20
|
0.27
|
1.19
|
12.86
|
2.095
|
4.397
|
|
pH of buffer + 0.2
|
2.850
|
4.352
|
2630
|
7622
|
1.52
|
1.24
|
1.00
|
0.74
|
6.73
|
2.686
|
4.400
|
|
Quantity of PDP − 10%
|
2.376
|
4.632
|
2764
|
7875
|
1.53
|
1.22
|
0.32
|
0.66
|
11.16
|
2.340
|
4.593
|
|
Quantity of PDP + 10%
|
2.384
|
4.588
|
3038
|
6916
|
1.47
|
1.24
|
0.62
|
0.52
|
10.05
|
2.468
|
4.531
|
|
Quantity of OSASS − 10%
|
2.370
|
4.432
|
2961
|
7251
|
1.46
|
1.24
|
1.15
|
0.83
|
10.01
|
2.356
|
4.417
|
|
Quantity of OSASS + 10%
|
2.456
|
4.421
|
2879
|
7066
|
1.43
|
1.20
|
0.50
|
0.89
|
9.46
|
2.487
|
4.505
|
|
Acceptance criteria
|
–
|
–
|
> 2000
|
NMT 2.0
|
≤ 2.0
|
NLT 2.0
|
Similar to standard
|
- Reso. = USP resolution between telmisartan and rosuvastatin peak
