扎西他宾渗透泵控释片含量测定方法的建立  

Establishment of Content Determination Method of Zalcitabine in Osmotic Pump Controlled-Release Tablet

作　　者：张可蕊 王宇驰 张颖[1] 李旭东 周安琪 张晓萍 Zhang Ke-rui;Wang Yu-chi;Zhang Ying;Li Xun-dong;Zhou An-qi;Zhang Xiao-ping(Antibiotics Research and Re-evaluation Key Laboratory of Sichuan Province,Sichuan Industrial Institute of Antibiotics,School of Pharmacy,Chengdu University,chengdu 610052)

机构地区：[1]抗生素研究与再评价四川省重点实验室,四川抗菌素工业研究所,药学院,成都大学,成都610052

出　　处：《国外医药（抗生素分册）》2021年第4期252-256,共5页World Notes on Antibiotics

基　　金：抗生素研究与再评价四川省重点实施室开放课题(ARRLKF14-03)。

摘　　要：目的建立扎西他宾渗透泵控释片含量的高效液相测定方法,为研发时的质量控制提供检测方法。方法确定了扎西他宾的最大吸收波长和稳定性,采用HPLC法,以Welchrom®C18(250×4.6mm,5μm)为色谱柱,25mmol/L磷酸二氢钾溶液(磷酸调pH=2.2,加入1.08g/L 1-辛烷磺酸钠,混匀)-乙腈(v/v=85:15)为流动相,流速为1.5mL/min,检测波长为280nm,进样量为100μL,柱温为30℃,洗脱方式为等度洗脱。结论建立的HPLC检测方法操作简便,专属性强,结果准确,可用于扎西他宾渗透泵控释片的含量测定。Objective To establish a method for determining the content of zalcitabine in osmotic pump controlled-release tablet by HPLC,and to provide a detection method for quality control during research and development.Methods The maximum absorption wavelength and stability of zalcitabine were determined.The HPLC method was used for content determination of zalcitabine in osmotic pump controlled-release tablet.Isocratic elution at a flow rate of 1.0 mL/min was employed on a Welchrom®C18(250×4.6mm,5μm)analytical column maintained at 30℃.The mobile phase was a mixture of 25mmol/L potassium dihydrogen phosphate solution(adjust pH to 2.2 with phosphoric acid)and 1.08g/L sodium 1-octane sulfonate-acetonitrile(v/v=85:15).The UV detection wavelength was performed at 280nm and 100μL of sample was injected.Conclusion The method has passed the methodological verification,which can be used for determining the content of zalcitabine in osmotic pump controlled-release tablet.

关 键 词：扎西他宾 渗透泵控释片 高效液相法 含量测定 

分 类 号：R979.9[医药卫生—药品]