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1448969 
Journal Article 
Evaluation of a short stability-indicating HPLC method for diclofenac sodium gels 
Korodi, T; Bukowski, K; Lachmann, B 
2012 
Yes 
Die Pharmazie
ISSN: 0031-7144 
67 
12 
980-983 
23346758 
WOS:000311883800003 
A fast and reproducible high performance liquid chromatography method has been developed for the determination of diclofenac sodium and its degradation products in commercial and in in-house produced ointments. The method employs a RP-LiChrospher (R) select B (C8) column with a mobile phase containing methanol/water (63:37, v/v) and detection at 220 nm. This rapid and simple HPLC assay was used for QA/QC of large scale in-house produced diclofenac gel. The validation protocol was designed following international guidelines, e.g. ICH Q2(R1). Selectivity tests also included the separation of synthesis related by-products like 1-(2,6-dichlorphenyl)indoline-2-one (impurity A) and indoline-2-one (impurity E), and in addition selectivity with regard to several photodegradation products produced by both UV and simulated sunlight irradiation has been shown. 
IRIS
• Methanol (Non-Cancer)
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