211 / 227
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3DJH RI
Table-62: ERH-46: Weight of sample: 4071mg - 100ml with methanol
Actual quantity in
the weight taken
Marker
Actual
content
(% w/w)
Weight
of
sample
(mg)
100 ml
1 ml
Quanti
ty
added
(mg)
Purity
Total
Quantity
(mg)
Calculated
Values
(%w/w)
Observed
Value
(%w/w)
Recovery
(%w/w)
W-IV
0.155
6.3
0.063
0.164
90
0.211
0.506
0.515
101.82
W-V
0.151
6.1
0.061
0.056
90
0.112
0.268
0.272
101.21
WF-A
0.130
5.3
0.053
0.230
99
0.281
0.674
0.678
100.71
12-D
0.037
1.5
0.015
0.190
95
0.196
0.469
0.477
101.64
W –A
0.039
1.6
0.016
0.160
99
0.174
0.418
0.416
99.57
W –B
0.010
4071
0.4
0.004
0.156
99
0.159
0.380
0.283
74.31
4.5.6) Conclusion:
Table-63:
Batch No.
Withanoside IV
Withanoside V
Withaferin A
12-Deoxy
withastramonolide
Withanolide
A
Withanolide
B
WS/06Lot08
100.6
99.8
99.9
100.9
97.3
75.0
WS/06Lot10
94.6
97.4
95.9
93.4
97.2
99.3
WS/05Lot20
101.5
100.1
99.6
101.0
98.4
73.7
WS/05Lot21
96.5
96.5
99.2
93.7
93.7
106.5
RD/1170
95.9
95.8
97.3
97.2
96.4
98.1
RD/1045
99.8
100.3
100.3
101.4
96.3
74.9
RD/1162 RM
99.0
95.3
98.8
91.2
94.5
97.5
ERH-46 RM
101.8
101.2
100.7
101.6
99.6
74.3
Spike recovery of Total withanolides is within the acceptance criteria indicating the method is
accurate.
Enclosure-11:
Sample chromatograms
(8 Pages).