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用正相高效液相色谱法测定原料药、混合片及单一片中氢化可的松的含量,用朴热息痛作内标。测定结果:平均回收率为98.5%;变异系数:原料药为0.97%;混合片为1.6%;单一片为2.7%。并用红外光谱法及薄层色谱法作氢化可的松的鉴定,结果满意。此法已正式通过作为法定的操作方法。1.高效液相色谱法与条件:色谱柱:25cm×4.6mm id 不锈钢柱,用5～6μm 直径的全多
The content of hydrocortisone in drug substance, tablet and single tablet was determined by normal-phase high performance liquid chromatography. The results showed that the average recovery was 98.5%. The coefficient of variation was 0.97% for the drug substance, 1.6% for the mixed tablet and 2.7% for the single tablet. The results of the determination of hydrocortisone by infrared spectroscopy and thin layer chromatography were satisfactory. This law has been formally adopted as a statutory method of operation. 1. High Performance Liquid Chromatography and Conditions: Column: 25cm × 4.6mm id stainless steel column, with a total of 5 ~ 6μm diameter