Department of Chemistry, University of Lahore, Lahore, Pakistan.
Department of Biochemistry, Government College University Faisalabad, Faisalabad, Pakistan.
Biomed Chromatogr. 2021 Mar;35(3):e4997. doi: 10.1002/bmc.4997. Epub 2020 Oct 27.
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 C 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 and the limits of quantification were 20.204 and 20.628 μm ml 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.
本研究根据国际协调会议指南，开发了一种准确、简单、经济、精确和可重现的反相高效液相色谱法，用于测定乳膏制剂中的夫西地酸和醋酸氢化可的松。通过等度洗脱，在 Shimadzu 反相高压液相色谱仪上实现色谱分离，采用 C 柱（150×4.6mm，5μm）和 UV 检测器在 225nm 波长处，以乙腈和 0.05%三氟乙酸（60:40）为流动相和稀释剂，流速为 2ml/min，进样量为 20μl。校准曲线的浓度范围为 80-120%，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%。醋酸氢化可的松和夫西地酸的检测限分别为 6.0667μm ml 和 6.807μm ml，定量限分别为 20.204μm ml 和 20.628μm ml。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可接受标准范围内。该方法被发现是经过验证的，简单、快速，适用于反相高效液相色谱法同时测定醋酸氢化可的松和夫西地酸，可用于质量控制的常规分析测试，运行时间为 8 分钟。
