stability-indicating methods for the determination of sertaconazole nitrate by micelle-enhanced spectrofluorimetry and tlc-densitometry

Two sensitive and selective stability−indicating methods were developed for the determination of sertaconazole nitrate (Ser-NO₃), in the presence of its acid, alkaline and oxidative degradation products. The first method was based on measuring the fluorescence intensity of the drug at λ_ex/λem = 231 nm/312 nm. The influence of micelle medium on the fluorescence emission was studied. The nonionic surfactant of Triton^® X−100 showed strong sensitizing effect for the fluorescence. The fluorescence intensity plot was linear over concentrations 0.5−5 µg mL^-1 with mean percentage recoveries 100.59 plus or minus 1.49 %. The second method was based on TLC separation of the drug from its degradation products followed by densitometric measurement of the intact drug spot at 302 nm. The developing system used for separation was chloroform−acetone−33 % ammonia (14:2:0.1 v/v/v). The linear range was 1−8 μg/spot with mean percentage recoveries 100.07 plus or minus 1.97 %. The methods were validated according to ICH guidelines. Statistical analysis of the results revealed high accuracy and good precision. The suggested procedures could be used for the determination of sertaconazole nitrate in drug substance and drug products as well as in presence of its degradation products.