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-中国药房.PDFVIP

·药品监督· 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 ＊ 施 捷 ，车宝泉，尹 光（北京市药品检验所，北京 100035） 中图分类号 R927.11 文献标志码 A 文章编号 1001-0408（2015）04-0538-03 DOI 10.6039/j.issn. 1001-0408.2015.04.34 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1ng ；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。 关键词 左炔诺孕酮；右旋体；原料药；片剂；高效液相色谱法 Investigation of Dextroisomer in Levonorgestrel Drug Substance and Levonorgestrel Tablets from Different Manufacturers SHI Jie ，CHE Bao-quan ，YIN Guang （Beijing Institute for Drug Control ，Beijing 100035，China ） ABSTRACT OBJECTIVE ：To investigate if any inactive dextroisomer is in levonorgestrel drug substance or Levonorgestrel tab- lets from different sources ，and to investigate levonorgestrel drug substance treated with heat ，moisture and light to study the change of storage. METHODS ：HPLC method was adopted. The determination was performed on Hypersil ODS column with mo- bile phase consisted of methanol- 1％γ-cyclodextrin （50∶50）at the flow rate of 1.2 ml/min. The detection wavelength was set at 242 nm ，and the column temperature was 30 ℃. The inactive dextroisomer were analyzed in 11batches of drug substance from 2 manufacturers ，19batches of tablet from 7manufacturers （containing 1batch of sample after kept for 3years ），2batches of enter- ic-coated tablet from 1manufacturer ，original tablet and drug substance treated with heat ，moisture and light. RESULTS ：Dextroiso- mer was well separated from levonorgestrel under above chromatogram condition ，and the limit of detection was 1ng. No dextroiso- mer was found in samples. CONCLUSIONS ：Established method is specific ，sensitive and en