反相高效液相色谱法测定法莫替丁片含量——中国药典(2000版)和美国药典(26版)方法的比较  

The determination of the content of famotidine using RP-HPLC——comparison of the determination method of ChP(2000 version) and USP(26 version)

作　　者：谈珺珺[1] 谷薇薇[2] 王金萍[2] 刘伟[2] 张黎娟[2] 刘利苹 张福田 

机构地区：[1]安徽师范大学化学与材料科学学院,安徽芜湖241000 [2]安徽中医学院,安徽合肥230031 [3]合肥大众医药科技开发有限责任公司,安徽合肥230031

出　　处：《安徽医药》2005年第3期197-199,共3页Anhui Medical and Pharmaceutical Journal

摘　　要：目的 用RP-HPLC测定法莫替丁片含量,并将中国药典(2000版)与美国药典(26版)两种方法进行比较.方法 用反相高效液相色谱测定法莫替丁片含量.中国药典(2000版)色谱条件:C18柱,以庚烷磺酸钠溶液(取庚烷磺酸钠2.0 g,加水900ml溶解后,用冰醋酸调节pH至3.9,加水至1000 ml)-乙腈-甲醇(25:6:1)为流动相,检测波长254 nm.美国药典(26版)色谱条件:C18柱,以水-甲醇-磷酸二氢钾缓冲液(31:6:3,用磷酸调节pH至5.0)为流动相,检测波长254 nm.结果 中国药典(2000版)方法法莫替丁在0.012 5～0.20 g·L-1浓度范围内,浓度与峰面积线性关系良好,相关系数r=0.999 9.美国药典(26版)方法法莫替丁在0.002 024～0.202 4 g·L-1浓度范围内,浓度与峰面积线性关系良好,相关系数r=0.999 9.结论 二者法莫替丁浓度与峰面积都具有良好的线性关系,但美国药典(26版)与中国药典方法(2000年版)相比,峰面积较小,但流动相成本较低,易得,更安全.Aim The content of famotidine was determined using the RP-HPLC with comparison of ChP (2000 version) and USP (26 version). Methods The content of famotidine was determined using the RP-HPLC method The chromatographic conditions at the ChP included the C18 column and the mobile phase was composed of sodium heptanesulfonate (dissolve 2.0 g of sodium-heptanesulfonate in 900 ml of water and adjusted pH to 3.9 by acetic-acid, diluted with water of 1 000 ml)-acetonitrile-methanol (25 ∶6 ∶1). The detection wavelength was 254 nm. The chromatographic conditions at the USP included the C 18 column and the mobile phase was water-methanol-monobasic potassium phosphate buffer solution(31 ∶6 ∶3 and adjusted pH to 5.0 by acetic-acid). The detection wavelength was at 254 nm. Results The linearity was obtained over 0.0125～0.20 g·L -1 (r= 0.999 9 ) for famotidine at the ChP (2000 version) and the linear relation was good. At the USP(26 version) the linearity was obtained over 0.002 024 ～ 0.202 4 g·L -1 (r= 0.999 9 )and the linear relation was good.Conclusions The two linear relation was very good with the density and the peak area. But the USP compares with the ChP to the peak area is lower, but the cost of mobile phase is lower, safer.

关 键 词：法莫替丁 美国药典 中国药典 含量 色谱条件 反相高效液相色谱法 RP-HPLC测定 浓度 C18柱 加水 

分 类 号：R927[医药卫生—药学] R573