地诺孕素液相分离条件评估数据

地诺孕素液相分离方法改进。地诺孕素是一种混合孕激素，同时具有天然和合成孕激素的药理学有点，主要用于治疗子宫内膜异位症。在地诺孕素的生产、贮藏、运输和使用过程中可能会带入一些原料、中间体或副产物，因此如何快速有效的分析分离相关物质是非常重要的。按照药典使用C18色谱柱，样品浓度在1mg/ml的条件下，对检测波长、流动相、柱温、流速四个条件设计不同数值进行平行试验，借助大数据分析技术，对相关结果进行全面评估，筛选出不同普遍有效的液相条件，为地诺孕素杂质液相检测提供精准数据。地诺孕素液相分离条件评估数据算法规则包括如下步骤： 第一，条件设置：检测波长220nm、260nm、310nm；流动相为甲醇-乙腈溶液，其体积比分别为60：40，65：35和70：30。柱温分别为30℃、35℃、40℃；流速为0.8ml/min、1.0ml/min、1.2ml/min。以地诺孕素分离度和杂质出峰个数为指标，考察不同条件下的杂质分离效能； 第二，数据算法：地诺孕素分离度在5.00及以上得3分，4.00~5.00得2分，3.00~4.00得1分，3.00以下及未分离不得分，得分填入右侧的评分列；杂质出峰个数6~7个得2分，4~5个得1分，3个及以下不得分，得分填入右侧的评分列。将上述分数相加，得到总分，填入总分列。总分高的液相条件作为优选。

Improved Liquid Phase Separation Method for Dienogest
Dienogest is a mixed progestogen with pharmacological advantages of both natural and synthetic progestogens, which is mainly used for the treatment of endometriosis. During the production, storage, transportation and application of dienogest, raw materials, intermediates or by-products may be introduced, so it is of great importance to rapidly and effectively analyze and separate related substances. Using a C18 chromatographic column according to pharmacopeia specifications with a sample concentration of 1 mg/ml, parallel experiments were designed with different values for four parameters: detection wavelength, mobile phase, column temperature and flow rate. Comprehensive evaluation of the relevant results was carried out with the aid of big data analysis technology, and universally effective liquid phase conditions were screened out to provide accurate data for liquid phase detection of dienogest impurities.
The algorithm rules for evaluating liquid phase separation conditions of dienogest include the following steps:
Step 1: Condition Setup: Detection wavelengths are set as 220 nm, 260 nm and 310 nm; the mobile phase is a methanol-acetonitrile solution with volume ratios of 60:40, 65:35 and 70:30 respectively. Column temperatures are 30℃, 35℃ and 40℃; flow rates are 0.8 ml/min, 1.0 ml/min and 1.2 ml/min. Taking the separation degree of dienogest and the number of impurity peaks as indicators, the impurity separation efficiency under different conditions was investigated;
Step 2: Data Algorithm: A score of 3 is awarded when the separation degree of dienogest is 5.00 or above, 2 points for 4.00–5.00, 1 point for 3.00–4.00, and 0 points for values below 3.00 or unseparated cases, with the scores filled in the corresponding score column; for the number of impurity peaks, 2 points are given for 6–7 peaks, 1 point for 4–5 peaks, and 0 points for 3 or fewer peaks, with the scores filled in the corresponding score column. The aforementioned scores are summed to obtain the total score, which is filled in the total score column. Liquid phase conditions with higher total scores are selected as the optimal ones.

搜集汇总

背景与挑战

背景概述

该数据集专注于地诺孕素液相分离方法的优化评估，通过设计多条件平行试验（包括检测波长、流动相、柱温和流速），结合分离度和杂质出峰个数的评分算法，系统筛选高效液相条件。其核心目标是提升地诺孕素杂质检测的准确性和效率，为药物生产与质量控制提供数据支持。