罗红霉素颗粒和干混悬剂中降解产物HPLC测定方法建立及降解产物产生原因探讨  

Development of the HPLC methods of the production for the degradation product in roxithromycin granules and roxithromycin for suspension and discussion on the cause of degradation products

作　　者：曾红霞[1] 张凤妹[1] 王建 

机构地区：[1]浙江工业大学,杭州310014 [2]浙江省食品药品检验研究院,杭州310004

出　　处：《中国抗生素杂志》2013年第11期834-839,共6页Chinese Journal of Antibiotics

摘　　要：目的建立罗红霉素颗粒和干混悬剂中降解产物去红霉糖罗红霉素的rteLcN定方法，并探讨了降解产物去红霉糖罗红霉素产生的原因。方法色谱柱为DiamonsilC18柱，流动相A为磷酸盐缓冲液（pH4．3）．乙腈（74：26），流动相B为水一乙腈（30：70），线性梯度洗脱，检测波长为210nm。结果降解产物峰能与其他成分峰有效分离，在2．0～20．0gg／mL范围内呈良好的线性关系（r=0．9998），罗红霉素颗粒和干混悬剂的平均回收率分别为103．5％（n=9）和103．9％（H=9），重复性RSD为4．9％（n=6），定量限为1．0gg／mL和检测限为0．2gg／mL。结论结果表明，产品的处方显酸性是产生降解产物的原因。该方法准确、简便、灵敏，可用于本品的质量控制，为下版中国药典罗红霉素颗粒和干混悬剂标准中增订降解产物去红霉糖罗红霉素检查和产品处方改进提供了科学的依据。Objective To develop a HPLC method for the determination of degradation product in roxithromycin granules and roxithromycin for suspension, and study the cause of production for the degradation product. Methods The column was Diamonsil C18. The mobile phase consisted of phosphate buffer（pH4.3）- acetonitrile（74：26）（A） and water- acetonitrile（30：70）（B） with gradient program. The detection wavelength was 210nm. Results Good separation of degradation product and othe rcomponents could be achieved in the chromatographic condition. The linear range was 2.0-20.0ktg/mL（r=0.9998）. The average recoveries for roxithromycin granules and roxithromycin for suspension were 103.5%（n=9）and 103.9%（n=9） respectively. The RSD of precision was 4.9%（n=6）. The limit of quantitation was 1.0~tg/mL. The detection limit was 0.2~tg/mL. Conclusion The result showed that acidic formulation was the reason of product degradation. Moreover, the method is accurate, simple, sensitive, and can be used for quality control of roxithromycin granules and roxithromycin for suspension. The method provide a scientific basis on adding control of the degradation products descladinose roxithromycin for next edition of the Chinese Pharmacopoeia and improvement of product formulation.

关 键 词：罗红霉素颗粒 罗红霉素干混悬剂 降解产物 去红霉糖罗红霉素 HPLC 

分 类 号：R927.1[医药卫生—药学]