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


Figure 8 ) and  Limit of quantitation (LOQ) ( Figure 9



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cost-effective-quantification-of-trace-level-edta-ethylene-diamine-tetraacetic-acid-by-titrimetry-in-active-pharmaceutical-ingredi

Figure 8
) and 
Limit of quantitation (LOQ) (
Figure 9
) were found to be 0.0160% and 0.0350% respectively. Optical characteristics 
results are summarized in (
Table 7
).
Figure 7: 
Titration curve of EDTA Vs Copper sulphate.


Nagaraju 
et al
Der Chemica Sinica, 2017, 8(1):175-183
Pelagia Research Library
182
Figure 8:
Titration curve of limit of detection.
Figure 9: 
Titration curve of limit of quantification.
Table 7: 
Optical characteristics of EDTA content in pharmaceutical drug substances.
Parameters
Results
Linearity range (%w/w)
0.0350-0.150
Regression equation (y=mx+c)
y=0.3497x+0.0090
Correlation coefficient (r
2
)
0.9991
LOQ (%w/w)
0.0350
LOD (%w/w)
0.0160
CONCLUSION
Quantification of EDTA content Method was developed in pharmaceutical drug substances and validated as per the 
ICH [15] Guidelines.
ACKNOWLEDGEMENTS
The authors express their sincere gratitude to APL Research Centre-II (A division of Aurobindo Pharma Ltd) located 
at Hyderabad, India, for providing the analytical support to pursue this work and are also grateful to colleagues who 
helped us in this work and also thankful to the authorities of Andhra university.


Nagaraju 
et al
Der Chemica Sinica, 2017, 8(1):175-183
Pelagia Research Library
183
REFERENCES
[1] 
Heydari R, Shamsipur M, Naleini N (
2013
) Simultaneoous determination of EDTA, Sorbic acid and Diclofenac sodium in 
pharmaceutical preparation using High-Performacne Liquid chromatography. 
AAPS PharmSciTech
14: 764-769.
[2] 
Cagnasso CE, Lo´pez LB, Rodrı´guez VG, Valencia ME (
2007
) Development and validation of a method for the determination 
of EDTA in non-alcoholic drinks by HPLC. 
J Food Comp Anal
20: 248-251.
[3] 
Johnston MB, BernardJr AJ, Flaschka HA (

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