Faculty of Pharmacy, Rhodes University, Grahamstown, South Africa.
J Sep Sci. 2013 Mar;36(5):849-56. doi: 10.1002/jssc.201200969. Epub 2013 Jan 28.
A rapid, simple, stability-indicating forced degradation study of clobetasol 17-propionate was conducted using RP-HPLC. The method was used to analyze clobetasol 17-propionate in methanol, propylene glycol, and a cream formulation. Isocratic elution of clobetasol and its degradation products was achieved using a Nova-Pak® 4 μm C18 150 mm × 3.9 mm id cartridge column and a mobile phase of methanol: water (68:32 v/v) at a flow rate of 0.9 mL min(-1). Quantitation was achieved with UV detection at 239 nm. Nondegraded clobetasol was eluted at a retention time of 6.0 min. Clobetasol 17-propionate was subjected to different stress conditions viz., acidic, basic, heat, oxidation, light, and neutral hydrolysis. The greatest degradation occurred under strong base and oxidative conditions. Strong base-degraded clobetasol produced additional peaks at retention times of 1.8, 4.0, 5.0, and 8.0 min and clobetasol oxidation degradation peaks eluted at 2.2 and 24 min. Complete validation was performed for linearity, accuracy, and precision over the concentration range 0.15-15 μg mL(-1). All data were analyzed statistically and this RP-HPLC method proved to be accurate, precise, linear, and stability indicating for the quantitation of clobetasol 17-propionate in methanol, propylene glycol, and cream formulations.
采用反相高效液相色谱法（RP-HPLC）对氯倍他索 17-丙酸酯进行了快速、简单、专属性的强制降解研究。该方法用于分析甲醇、丙二醇和乳膏制剂中的氯倍他索 17-丙酸酯。采用 Nova-Pak® 4μm C18 150mm×3.9mm id 柱和甲醇：水（68：32v/v）等度洗脱，流速为 0.9mL/min，实现了氯倍他索及其降解产物的分离。在 239nm 处用紫外检测进行定量。未降解的氯倍他索在保留时间为 6.0min 处洗脱。氯倍他索 17-丙酸酯分别在酸性、碱性、热、氧化、光照和中性水解等不同的应力条件下进行了考察。在强碱和氧化条件下，其降解最为严重。强碱降解的氯倍他索在保留时间为 1.8、4.0、5.0 和 8.0min 处产生了额外的峰，而氯倍他索氧化降解的峰则在 2.2 和 24min 处洗脱。在 0.15-15μg/mL 浓度范围内对线性、准确性和精密度进行了全面验证。所有数据均进行了统计学分析，该反相高效液相色谱法证明准确、精密、线性，并可用于甲醇、丙二醇和乳膏制剂中氯倍他索 17-丙酸酯的定量分析。
