Professional Documents
Culture Documents
Divya et al
ISSN 2349-7750
ISSN: 2349-7750
PHARMACEUTICAL SCIENCES
Available online at: http://www.iajps.com
Research Article
Corresponding author:
N. Divya,
Joginpally B R Pharmacy College,
Hyderabad, Telangana
divyasreenallamothu65@gmail.com
QR code
Please cite this article in press as Divya et al, Validated Stability-Indicating RP-HPLC Method for
Determination of Ibrutinib, Indo Am. J. Pharm. Sci, 2016; 3(4).
www.iajps.com
Page 324
www.iajps.com
Divya et al
ISSN 2349-7750
Page 325
Divya et al
ISSN 2349-7750
PeakName
Ibrutinib
Ibrutinib
Ibrutinib
Ibrutinib
Ibrutinib
Ibrutinib
Mean
Area
1144018
1157129
1134468
1146943
1132425
1153109
1144682
Std.Dev.
9859.56
%RSD
0.86
1
2
3
4
5
6
RT
3.052
3.052
3.053
3.055
3.055
3.056
USP Tailing
1.31
1.33
1.34
1.32
1.30
1.32
www.iajps.com
Concentration (ppm)
0
35
70
105
140
175
210
Area
0
276279
570114
862544
1179328
1416511
1700873
Page 326
% Level
50%
100%
150%
Divya et al
ISSN 2349-7750
Amount Spiked
(g/mL)
70
70
70
140
140
140
210
210
210
71.66
70.55
69.82
140.52
140.26
140.59
210.41
208.53
209.80
Mean %Recovery
102.4
100.8
99.7
100.37
100.18
100.42
100.20
99.30
99.91
100.36%
Peak Area
1161542
1168399
1139374
1140998
1158685
1157806
1154467
11681.7
1.01
Table 5: Intermediate Precision Data
Peak Area
1135518
1155202
1172667
1173988
1178878
1166121
17488.4
1.50
Table 6: Robustness Data
S.No
1
2
3
4
5
AVG
STDEV
%RSD
Parameter
Flow Minus
Flow Plus
Mobile phase Minus
Mobile phase Plus
Temperature minus
Temperature plus
%RSD
0.0
0.3
0.1
0.1
0.3
0.2
www.iajps.com
Degradation
condition
Acid
Alkali
Oxidation
Thermal
UV
Water
%Drug degraded
Purity Angle
Purity Threshold
3.512
2.564
4.246
1.231
0.499
0.573
0.18
0.182
0.211
0.182
0.179
0.187
0.245
0.248
0.252
0.252
0.251
0.247
Page 327
Divya et al
ISSN 2349-7750
www.iajps.com
Page 328
Divya et al
ISSN 2349-7750
www.iajps.com
Page 329
Divya et al
ISSN 2349-7750
www.iajps.com
Page 330