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Drug development and industrial pharmacy, v.25 no.3, 1999년, pp.379 - 385
Ho, Chih (Division of Pharmaceutical Chemistry, National Laboratories of Foods and Drugs, Taipei, Taiwan, Republic of China) , Huang, Hsi-Min (Division of Pharmaceutical Chemistry, National Laboratories of Foods and Drugs, Taipei, Taiwan, Republic of China) , Hsu, Shu-Ying (Division of Pharmaceutical Chemistry, National Laboratories of Foods and Drugs, Taipei, Taiwan, Republic of China) , Shaw, Ching-Yih (Division of Pharmaceutical Chemistry, National Laboratories of Foods and Drugs, Taipei, Taiwan, Republic of China) , Chang, Ber-Lin (Division of Pharmaceutical Chemistry, National Laboratories of Foods and Drugs, Taipei, Taiwan, Republic of China)
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 (15cm × 4.6 mm ID) of Inertsil ODS-2 (5 &mgr;m) was used, and 0.04M 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.
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