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ZENODO
Article . 2026
License: CC BY
Data sources: ZENODO
ZENODO
Article . 2026
License: CC BY
Data sources: Datacite
ZENODO
Article . 2026
License: CC BY
Data sources: Datacite
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DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING RP-UPLC METHOD FOR THE ASSAY AND RELATED SUBSTANCES OF DICLOFENAC SODIUM IN ITS INJECTABLE FORMULATION

Authors: Dr. Ch. Saibabu*1, J. Praveena2, Dr. M. Bhaskar3;

DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING RP-UPLC METHOD FOR THE ASSAY AND RELATED SUBSTANCES OF DICLOFENAC SODIUM IN ITS INJECTABLE FORMULATION

Abstract

Development and validation of a challenging and multipurpose stability-indicating RP-UPLC assay and related substances method for the quantification of diclofenac sodium and its impurities in its injection, in the presence of its degradation products. Various stress conditions, e.g. acid, base, oxidation, thermal and UV radiation has been employed to assess the stability indicating nature of the method. The desired chromatographic separation was achieved on a reverse phase ACQUITY UPLC® BEH SHIELD RP18 50mm x 2.1mm, 1.7µm under isocratic condition with a short run time of 5 minutes. A mixture of Triethylamine buffer of pH 2.0 and Methanol was used as Mobile phase with a flow rate of 0.35mL/min. Quantitation was achieved by UV detection at 254 nm. The method was validated for Linearity, Accuracy, Precision, Specificity, LOQ and Robustness. A linear response (r2>0.99) was observed for Diclofenac and its impurity in the range of 0.2µg/mL – 230 µg/mL and 0.3µg/mL – 4.8µg/mL respectively. The Limit of Quantitation (LOQ) for diclofenac sodium and its impurity were 0.2μg/ml and 0.3 µg/ml respectively. The proposed method can be used in quality control for the determination of the diclofenac sodium and its impurity in its injection and for the stability studies as the method separates the drug from its related/degradation products and excipients.

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
Average