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 (
Dostları ilə paylaş: