HPLC法用于西咪替丁片含量及溶出度的测定研究  

Determination of the Content and Dissolution in Cimetidine Tablets by HPLC

作　　者：傅小红 姜伟 万婷 张思甜 Fu Xiaohong;Jiang Wei;Wan Ting;Zhang Sitian(Nanchang Inspection and Testing Center,Nanchang 330000,China)

机构地区：[1]南昌市检验检测中心,江西南昌330000

出　　处：《云南化工》2022年第8期62-65,共4页Yunnan Chemical Technology

摘　　要：建立了高效液相色谱法测定西咪替丁片含量及溶出度的实验方法。采用Agilent TC-C_(18)(∅4.6 mm×250 mm,5μm)为色谱柱,以甲醇-水(体积比300∶700)(每1000 mL中含0.3 mL磷酸和0.94 g己烷磺酸钠)为流动相,流速为1.0 mL/min,检测波长为220 nm,柱温为25℃,进样量为10μL。实验表明,建立的实验方法在22.73~341.01μg/mL范围内相关系性良好,重复性相对标准偏差为0.4%,稳定性相对标准偏差为0.1%。所建立的实验方法与《中华人民共和国药典》2020版中西咪替丁片含量及溶出度测定结果相比较,HPLC法测定的含量及溶出度普遍比紫外吸收系数法所得的值低1%~4%。该方法专属更性强、准确度更高,更适用于西咪替丁片含量及溶出度的测定。A method for the determination of cimetidine tablets has been established by high performance liquid chromatography(HPLC).Agilent TC-C18(Φ4.6 mm×250 mm,5μm)was used as the chromatographic column,and methanol-water(300∶700)(0.3 mL phosphoric acid and 0.94 g sodium hexane sulfonate per 1000 mL)was used as mobile phase,the flow rate was 1.0 mL/min,the detection wavelength was set at 220 nm,the column temperature was 25℃,and the injection volume was 10μL.The results show that the established method has a good phase relationship in the range of 22.73~341.01μg/mL;the relative standard deviation of repeatability was 0.4%;and the relative standard deviation of stability was 0.1%.The established method was compared with the content and dissolution of cimetidine tablets determined by Chinese Pharmacopoeia(2020 edition),the content and dissolution of cimetidine tablets determined by HPLC were generally lower than determined by UV absorption coefficient method about 1%~4%,the established method is more exclusive and accurate,and more suitable for the determination of cimetidine tablets content and dissolution.

关 键 词：西咪替丁 溶出度 高效液相色谱法 

分 类 号：TQ460.72[医药卫生—药物分析学]