方案摘要
方案下载| 应用领域 | 制药 |
| 检测样本 | 原料药 |
| 检测项目 | 限度检查>异构体 |
| 参考标准 | 日本药典-Beraprost Sodium |
按日本药典规定的色谱方法，用YMC-Pack Pro C18色谱柱(P/N：AS12S05-1506WT)分离测定贝前列素钠异构体比例，分离度等完全满足药典规定。
Isomer ratio Dissolve 10 mg of Beraprost Sodium in 5 mL of methanol, and use this solution as the sample solution.Perform the test with 15 mL of the sample solution as directed under Liquid Chromatography <2.01> according to the following conditions, and determine the areas, Aa of the peak which appears at the retention time about 25 minutes, and Ab of the peak which appears at about 27 minutes: Ab/Aa is between 0.90 and 1.10.
Operating conditions—
Detector: An ultraviolet absorption photometer (wavelength:285 nm).
Column: A stainless steel column 6 mm in inside diameter and 15 cm in length, packed with octadecylsilanized silica gel for liquid chromatography (5 mm in particle diameter).
Column temperature: A constant temperature of about 40℃.
Mobile phase: A mixture of methanol, water and acetic acid (100) (600:400:1).
Flow rate: Adjust so that the retention time of the second eluting peak of beraprost is about 27 minutes.
System suitability—
System performance: When the procedure is run with 15 μL of the sample solution under the above operating conditions, the resolution between the two peaks of beraprost is not less than 1.2.
System repeatability: When the test is repeated 6 times with 15 μL of the sample solution under the above operating conditions, the relative standard deviation of the total area of the two peak of beraprost is not more than 2.0%.
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