ABSTRACT
The aim of this method is to study the stability of a potent Tri-Otic ear drop oily suspension non pharmacopoeia, as pharmaceutical dosage form four active ingredients. This ear drop consists from Triamcinolon acetonide as corticosteroid and Neomycin sulphate, Gramicidin as antibacterial agents as well as Nystatin as antifungal agent. This study based upon the accelerated stability study for many samples store at different temperatures 4, 25, 40°C, in amber colour glass containers for three months. The results were analyzed using HPLC technique for Triamcinolon acetonide degassing solution consists from highly purified water: acetonitril 30:70 [V/V%] as mobile phase with rate of flow 1.5 ml/ min, using ODS column. The spectrums were detected at 330 nm for maximum peak and area under the curve [AUC]. While biological methods used for analyzed both Neomycin sulphate and Nystatin. The media used for culture at 35-37°C for 7 days at pH 5.8-8 consist from potassium di hydrogen phosphate with sodium hydroxide for inhibition zone and applied biological assay. All active ingredients were extracted four times. From correlation between the concentration and time used by applying accelerated stability study data, according to the Arrhenius equation, we found the hydrolysis of oil suspension was pseudo first order K = Ln[2] /1 [0.5]. Our conclusion show that the Tri-Otic ear drop useful for two years approximately at 4°C