Abstract

A combination of Ofloxacin, Tinidazole, Terbinafine hydrochloride, and Clobetasol propionate is used for treatment, control, prevention, and improvement of bacterial and fungal skin infections. Two chromatographic methods (HPLC and HPTLC) were developed for the quantitative determination of these four drugs in their combined topical formulation. The HPLC method employed a C₁₈ (250 × 4.6 mm, 5 μ) column as a stationary phase and acetonitrile: 0.1% triethylamine (pH 3.5) with gradient elution as mobile phase. The chromatographic separation in HPTLC was carried out on precoated silica 60F₂₅₄ plates using toluene:ethyl acetate:methanol:triethylamine:formic acid (5:4:1:0.3:0.3 v/v/v/v/v) as mobile phase. Both methods used 238 nm as detection wavelength and were able to separate all four drugs with resolved and sharp peaks. Developed methods were validated as per ICH Q2(R1) guidelines. Both methods were found to be linear in selected ranges (r² > 0.998), precise (RSD < 2%), accurate (recovery > 99.5%), sensitive and specific for quantitation of all four drugs. Validated methods were successfully applied for the quantitative determination of four drugs in the cream formulation and assay results were found to be in good agreement with the stated amount of each drug. Assay results were statistically compared (t-test) and no significant difference was observed (p > 0.05) between the results obtained by both methods.

摘要

氧氟沙星、替硝唑、盐酸特比萘芬和丙酸氯倍他索的组合用于治疗、控制、预防和改善细菌和真菌皮肤感染。开发了两种色谱方法（HPLC 和 HPTLC）来定量测定这四种药物在其组合外用制剂中的含量。HPLC 方法采用 C ₁₈ (250 × 4.6 mm, 5 μ) 柱作为固定相，乙腈：0.1% 三乙胺 (pH 3.5) 梯度洗脱作为流动相。HPTLC 色谱分离在预涂硅胶 60F _{254 上进行}使用甲苯:乙酸乙酯:甲醇:三乙胺:甲酸 (5:4:1:0.3:0.3 v/v/v/v/v) 作为流动相。两种方法都使用 238 nm 作为检测波长，并且能够分离所有四种药物，并具有清晰的尖峰。开发的方法按照 ICH Q2(R1) 指南进行了验证。发现这两种方法在选定范围内均呈线性 ( r ² > 0.998)、精确 (RSD < 2%)、准确（回收​​率 > 99.5%）、灵敏且对所有四种药物的定量具有特异性。经验证的方法已成功应用于乳膏配方中四种药物的定量测定，发现测定结果与每种药物的规定量非常吻合。测定结果进行统计学比较（t检验），未观察到显着差异（p  > 0.05) 两种方法获得的结果之间。