不同厂家左炔诺孕酮原料药及片剂中右旋体存在状况考察

发布时间：2018-07-16 07:41

【摘要】：目的:考察不同厂家左炔诺孕酮原料药及片剂中是否存在无活性右旋体,并对高温、高湿、光照破坏的原料药进行考察,以了解贮存时的变化情况。方法:采用高效液相色谱法。色谱柱为Hypersil ODS,流动相为甲醇-1%γ-环糊精(50∶50),流速为1.2ml/min,检测波长为242nm,柱温为30℃。分析来源于2个厂家的11批次原料药、7个厂家的19批片剂(包括放置3年的1批样品)、1个厂家的2批肠溶片、原研片及经光、湿、热破坏的原料药中右旋体的存在情况。结果:在采用的色谱条件下,左炔诺孕酮与右旋体分离良好,右旋体检测限为1 ng;各检品中均未检出右旋体。结论:建立的方法专属性强、灵敏且环保;推导该药在原料合成时即可以控制左炔诺孕酮的光学纯度,制剂稳定性好,贮存期间不会因光、湿、热等因素产生右旋体。
[Abstract]:Objective: To investigate the existence of inactive dextra in the raw materials and tablets of levonorgestrel in different factories and to investigate the material of high temperature, high humidity and light damage to understand the change in storage. Method: high performance liquid chromatography was used. The chromatographic column was Hypersil ODS, the mobile phase was -1% gamma cyclodextrin (50: 50), and the flow rate was 1.2m L/min, with a detection wavelength of 242nm, and a column temperature of 30 C. Analysis of 11 batches of raw materials from 2 manufacturers, 19 batches of 7 manufacturers (including 1 batch of 3 years), 2 batch of enteric tablets in 1 manufacturers, the presence of dextra in raw and light, wet, and heat damaged materials. Results: under the chromatographic conditions, levonorgestrel and right The spin body was well separated and the dextral test was 1 ng, and no dextral body was detected in all the samples. Conclusion: the established method is highly specific, sensitive and environmentally friendly. The derivation of the drug can control the optical purity of levonorgestrel in the synthesis of raw materials, the preparation is stable, and the dextral body will not be produced by light, wet, heat and other factors during storage.
【作者单位】：北京市药品检验所;
【分类号】：R944

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