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 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.
Pharmacy Department, Krankenanstalt Rudolfstiftung, Vienna, Austria. thekla.korodi@wienkav.at
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T
Korodi
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K
Bukowski
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B
Lachmann
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000737:chemistry* / Q000528:radiation effects; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D004008:Diclofenac / Q000032:analysis / Q000737:chemistry* / Q000528:radiation effects; D004355:Drug Stability; D005782:Gels; D057230:Limit of Detection; D009824:Ointments / Q000032:analysis; D019999:Pharmaceutical Solutions / Q000032:analysis; D012015:Reference Standards; D015203:Reproducibility of Results; D013472:Sunlight; D014466:Ultraviolet Rays
D000894:Anti-Inflammatory Agents, Non-Steroidal; D005782:Gels; D009824:Ointments; D019999:Pharmaceutical Solutions; D004008:Diclofenac