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目的:建立同时测定复方维生素B6软膏中维生素B6和醋酸泼尼松含量的反相高效液相色谱法。方法:采用Hyper- sil C18柱(250 mm×4.0 mm,5μm),流动相为磷酸二氢钾,庚烷磺酸钠溶液(取磷酸二氢钾6.8 g,庚烷磺酸钠1.0 g,加水溶解并稀释至1 000 ml)-甲醇-三乙胺(35:65:0.3),用磷酸调pH值为3.2,检测波长242 nm。结果:维生素B6在22.12-176.8μg ·ml-1范围内,醋酸泼尼松在6.92-55.4 μg·ml-1。范围内呈线性关系,维生素B6的平均回收率为99.6%,RSD=1.09%(n= 5),醋酸泼尼松的平均回收率为99.6%,RSD=1.89%(n=5)。结论:本方法简便,结果准确,可用于本制刺的含量测定和质量控制。
Objective: To establish an RP-HPLC method for simultaneous determination of vitamin B6 and prednisone acetate in compound vitamin B6 ointment. Methods: Hyper-sil C18 column (250 mm × 4.0 mm, 5 μm) was used. The mobile phase consisted of potassium dihydrogen phosphate and sodium heptane sulfonate solution (6.8 g potassium dihydrogen phosphate and 1.0 g heptane sulfonate) Dissolved and diluted to 1000 ml) - methanol - triethylamine (35: 65: 0.3), adjusted to pH 3.2 with phosphoric acid, detection wavelength 242 nm. Results: In the range of 22.12-176.8 μg · ml-1 for vitamin B6 and prednisone acetate ranged from 6.92-55.4 μg · ml-1. The average recovery of vitamin B6 was 99.6% with RSD = 1.09% (n = 5). The average recovery of prednisone acetate was 99.6% with RSD = 1.89% (n = 5). Conclusion: The method is simple and accurate, and can be used for the determination and quality control of the stab.