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作 者:郑占伟[1] 张晴[1] 于兰[1] 祝仕清 ZHENG Zhan-wei;ZHANG Qing;YU Lan;ZHU Shi-qing(NCPC New Drug Research and Development Corporation Ltd.,National Engineering Research Center of Microbial Medicine,Hebei Industry Microbial Metabolic Engineering and Technology Research Center,Shijiazhuang 050015,China)
机构地区:[1]华北制药集团新药研究开发有限责任公司,微生物药物国家工程研究中心,河北省工业微生物代谢工程技术研究中心,河北石家庄050015
出 处:《化工管理》2018年第10期60-61,共2页Chemical Engineering Management
摘 要:目的 :建立HPLC法测定硝酸毛果芸香碱眼用凝胶的含量方法。方法 :采用十八烷基硅烷键合硅胶为填充剂的色谱柱(4.6mm×250mm,5μm);以醋酸盐缓冲液(pH4.5)(取醋酸钠4.9g与稀醋酸64 mL,加水溶解并稀释至1000mL,摇匀)-乙腈(85:15)为流动相;流速1.0 mL/min;检测波长为230 nm,柱温为室温,进样量20μL。结果 :硝酸毛果芸香碱线性范围为0.20089-0.60267mg/mL(r=0.9997);精密度、准确度、重复性试验RSD≤2.0%;加样回收率为100.4%(RSD=1.33%)。结论:该方法简便、准确、重复性好,可作为硝酸毛果芸香碱眼用凝胶含量的测定方法。OBJECTIVE:To establish a method for the content determination of pilocarpine nitrate eye gel by HPLC.METHODS:HPLC was performed on the column of C18 with mobile phase of acetate buffer solution(pH 4.5)-acetonitrile(85:15,V/V)at the flow rate of 1.0 mL/min,detection wavelength was 230 nm column temperature was room temperature,and the volume was 20μL.RESULTS:The pilocarpine nitrate linear range of was 0.20089~0.60267 mg/mL(r=0.9997);RSDs of precision,stability and reproducibility tests were all lower than 2.0%;recovery was 100.4%(RSD=1.33%).CONCLUSIONS:The method is simple,accurate,reproducible,and can be used for the content determination of pilocarpine nitrate eye gel.
关 键 词:HPLC法 硝酸毛果芸香碱眼用凝胶 含量
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