In this study, an accurate, simple, economical, precise and reproducible reversed‐phase HPLC method was developed for the estimation of fusidic acid and hydrocortisone acetate, according to the International Conference on Harmonization guidelines, in a cream formulation. Chromatographic separation was achieved by isocratic elution, on a Shimadzu reversed‐phased high‐pressure liquid chromatography instrument, equipped with a C₁₈ column (150 × 4.6 mm, 5 μm) and UV detector at 225 nm wavelength, using acetonitrile and 0.05% trifluoroacetic acid (60:40), as a mobile phase and diluent, at flow rate 2 ml/min and an injection volume of 20 μl. The calibration curves were acquired with concentration range 80–120% and mean percentage recoveries for hydrocortisone acetate and fusidic acid were 100.14 and 100.81%, respectively. The limits of detection was obtained as 6.0667 and 6.807 μm ml⁻¹ and the limits of quantification were 20.204 and 20.628 μm ml⁻¹ for hydrocortisone acetate and fusidic acid, respectively. All of the validation parameters were within the acceptance criteria, as per International Conference on Harmonization requirements, for hydrocortisone acetate and fusidic acid. This method was found to be validated, simple, rapid and applicable for the simultaneous estimation of hydrocortisone acetate and fusidic acid by reversed‐phased high‐pressure liquid chromatography, for routine analytical testing in quality control, with a run time of 8 min.

中文翻译：

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反相高效液相色谱法同时开发乳霜配方中乙酸氢化可的松和夫西地酸的分析方法并进行测定

在这项研究中，根据国际协调会议指南，在乳膏配方中，开发了一种准确，简单，经济，精确和可重现的反相HPLC方法，用于估计夫西地酸和乙酸氢化可的松。在配备C ₁₈的Shimadzu反相高压液相色谱仪上，通过等度洗脱实现色谱分离色谱柱（150×4.6 mm，5μm）和225 nm波长的UV检测器，使用乙腈和0.05％三氟乙酸（60:40）作为流动相和稀释剂，流速为2 ml / min，进样量为20微升 获得浓度范围为80-120％的校准曲线，醋酸氢化可的松和夫西地酸的平均回收率分别为100.14和100.81％。检出限为6.0667和6.807μmml ^-1，定量限为20.204和20.628μmml ^-1分别用于醋酸氢化可的松和夫西地酸。根据国际协调会议的要求，所有验证参数均在醋酸氢化可的松和夫西地酸的接受标准之内。该方法经验证，简便，快速，适用于反相高压液相色谱法同时评估乙酸氢化可的松和夫西地酸，用于质量控制的常规分析测试，运行时间为8分钟。