LC method for the analysis of Oxiconazole in pharmaceutical formulations

Method Validation

“…There are numerous method validation examples in the literature [9][10][11][12][13][14][15][16][17][18]. Each company has their own approach and own set of acceptance criteria for different analytical assays, but these approaches must be within the confines of their line unit QA department and be in accordance with any regulatory provisions.…”

Study of the forced degradation of isoconazole nitrate in bulk drug and cream formulations

“…13 In general, the stress test conditions were based on those suggested by the International Conference on Harmonisation (ICH). 14 For example, secnidazole 15 samples were incubated under the following hydrolytic conditions: in an acidic medium of 0.1 M HCl at 80 C for 12 h and in an alkaline medium of 0.1 M NaOH at 80 C for 8 h. For oxiconazole, 16 the acidic and basic solutions were refluxed at 100 C for 4 h. All imidazole drugs have been shown to be very labile in alkaline solutions (e.g., complete degradation of tinidazole 17 was observed in 0.1 M NaOH). The time of exposure to light of the drug in the photolytic studies ranged from a few hours (tenatoprazole) 18 to several days (tinidazole), and the studies were performed using drugs in either the solid form or in a solution.…”

“…19 Chromatographic techniques were utilised during our analysis of drug degradation, as they have been commonly employed for the analysis of drugs under stress conditions. 9,[15][16][17]20 Isoconazole…”

Spectrophotometric determination of oxiconazole in topical lotion using methyl orange

“…However, for oxiconazole (Ox), few reports about its analytical determination are available in the literature. High performance liquid chromatography of Ox in raw material and pharmaceutical formulations has been described [12]. Nevertheless, the literature has not showed spectrophotometric methods for determination of Ox in pharmaceutical formulations.…”