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3DJH RI
Table-52: Assay content of withanolides in sample: WS/06Lot10
Concentration
W –IV
W –V
WF-A
12-D
W –A
W –B
Sum
Trial -1
0.802
0.681
0.605
0.263
0.209
0.064
2.625
Trial -2
0.821
0.697
0.617
0.268
0.212
0.066
2.680
Trial -3
0.828
0.696
0.626
0.272
0.221
0.066
2.709
Concentration-1
(7.5mg/ml)
Trial -4
0.821
0.684
0.615
0.265
0.218
0.064
2.667
Trial -1
0.808
0.684
0.609
0.265
0.211
0.065
2.642
Trial -2
0.827
0.703
0.621
0.270
0.215
0.065
2.701
Trial -3
0.818
0.684
0.612
0.265
0.217
0.064
2.661
Concentration-2
(10.0mg/ml)
Trial -4
0.826
0.687
0.618
0.268
0.220
0.065
2.684
Trial -1
0.813
0.685
0.608
0.265
0.214
0.064
2.649
Trial -2
0.818
0.691
0.618
0.269
0.216
0.065
2.678
Trial -3
0.818
0.690
0.616
0.268
0.221
0.065
2.677
Concentration-3
(15.0mg/ml)
Trial -4
0.821
0.684
0.612
0.266
0.219
0.064
2.666
Trial -1
0.806
0.686
0.607
0.265
0.210
0.065
2.638
Trial -2
0.811
0.685
0.612
0.267
0.212
0.065
2.651
Trial -3
0.822
0.686
0.616
0.266
0.223
0.065
2.677
Concentration-4
(20.0mg/ml)
Trial -4
0.815
0.68
0.611
0.267
0.219
0.064
2.657
Trial -1
0.800
0.677
0.601
0.264
0.211
0.064
2.617
Trial -2
0.817
0.679
0.610
0.267
0.218
0.065
2.656
Concentration-5
(25.0mg/ml)
Trial -3
0.818
0.679
0.612
0.268
0.221
0.065
2.663
Mean
0.816
0.686
0.613
0.267
0.216
0.065
2.663
RSD
0.98
0.98
0.96
0.83
2.01
1.01
0.88
W-IV: Withanoside IV
W-V: Withanoside V
WF-A: Withaferin-A
12-D: 12-Deoxy Withastramonolide
W-A: Withanolide A
W-B: Withanolide B
4.4.5)
Conclusion:
Relative standard deviation of assay of sum of withanolides is < 1.0%
The above results indicate the method is precise and reproducible irrespective of the
sample concentration taken for analysis.
For standard chromatograms Enclosure – 5
Enclosure-9:
Sample chromatograms
(19 Pages).