Cost Effective Quantification of Trace Level edta (Ethylene Di-amine Tetra Acetic Acid) by Titrimetry in Active Pharmaceutical Ingredients

Table 2: Limit of Detection for precision.
n
EDTA Content(%w/w)
1
0.0151
2
0.0148
3
0.0136
4
0.0181
5
0.0181
6
0.0171
Mean
0.0161
SD^
0.0019
%RSD*
11.8
^ Standard deviation
* Relative standard deviation
Table 3: Limit of Quantification for precision.
n
EDTA Content(%w/w)
1
0.0356
2
0.0362
3
0.0362
4
0.0347
5
0.0335
6
0.0356
Mean
0.0353
SD^
0.001
%RSD*
2.83
^ Standard deviation
* Relative standard deviation
Table 4: System precision results of EDTA.
n
EDTA Content(%w/w)
1
0.0584
2
0.0599
3
0.0539
4
0.0570
5
0.0597
6
0.0602
Mean
0.0582
SD^
0.0024
%RSD
4.12
^ Standard deviation
* Relative standard deviation
Method Precision
Method precision was demonstrated by preparing six separate sample solutions were prepared using single batch of 
pharmaceutical drug substance spiking with known amount of EDTA spiked in sample solution and calculate the 
EDTA Content. Method precision results are tabulated in (Table 5).
Ruggedness (Intermediate precision)
Intermediate precision was performed by preparing six separate sample solution using single batch of pharmaceutical 

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Nagaraju et al
Der Chemica Sinica, 2017, 8(1):175-183
Pelagia Research Library
181
drug substance spiking with known amount of EDTA by different day, different analyst, different system and different 
electrode.