Evaluation of a short stability-indicating HPLC method for diclofenac sodium gels
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® select B (C8) column with a mobile phase containing...
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Veröffentlicht in: | Pharmazie 2012-12, Vol.67 (12), p.980-983 |
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Hauptverfasser: | , , |
Format: | Artikel |
Sprache: | eng |
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Zusammenfassung: | 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® 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. |
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ISSN: | 0031-7144 |
DOI: | 10.1691/ph.2012.2081 |