Ho C, Huang H M, Hsu S Y, Shaw C Y, Chang B L
National Laboratories of Foods and Drugs, Department of Health, Taipei, Taiwan, Republic of China.
Drug Dev Ind Pharm. 1999 Mar;25(3):379-85. doi: 10.1081/ddc-100102186.
A high-performance liquid chromatographic (HPLC) procedure for the simultaneous determination of famotidine (FMT), ranitidine HCl (RNT), cimetidine (CMT), and nizatidine (NZT) was developed using a two-level, full-factorial design with three variables (volume of methanol, percentage of triethylamine, and concentration of phosphate buffer) to select an acceptable mobile phase. A column (15 cm x 4.6 mm ID) of Inertsil ODS-2 (5 microns) was used, and 0.04 M aqueous sodium dihydrogen phosphate/acetonitrile/methanol/TEA at a proportion of 345/20/35/0.7 (v/v/v/v) was the selected mobile phase (1 ml/min). The detection wavelength was set at 230 nm, and procaine HCl was used as the internal standard. Precision and linearity of the method were assessed. None of the commercial samples was found to be outside the compendial limits of 90.0% to 110.0% of the claim amount.
采用二水平全因子设计，通过三个变量（甲醇体积、三乙胺百分比和磷酸盐缓冲液浓度）来选择合适的流动相，建立了一种同时测定法莫替丁（FMT）、盐酸雷尼替丁（RNT）、西咪替丁（CMT）和尼扎替丁（NZT）的高效液相色谱（HPLC）方法。使用了一根Inertsil ODS - 2（5微米）的色谱柱（15厘米×4.6毫米内径），选定的流动相为0.04 M磷酸二氢钠水溶液/乙腈/甲醇/三乙胺，比例为345/20/35/0.7（v/v/v/v）（流速1毫升/分钟）。检测波长设定为230纳米，使用盐酸普鲁卡因作为内标。评估了该方法的精密度和线性。未发现任何市售样品超出规定量的90.0%至110.0%的药典限度。
