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目的:建立HPLC测定枸橼酸铋雷尼替丁及其片剂中雷尼替丁含量的方法。方法:色谱柱为InertsilODS-3(4.6 mm×150 mm,5μm);磷酸盐缓冲液(取磷酸6.8 mL置1900 mL水中,加入50%氢氧化钠溶液8.6 mL,加水至2000 mL,用磷酸或50%氢氧化钠溶液调节pH至7.10±0.05)–乙腈(98∶2)及磷酸盐缓冲液–乙腈(78∶22)分别为流动相A、B,梯度洗脱;流速为1.2 mL.min-1,检测波长为230 nm,柱温为35℃;外标法。结果:本方法在2.5～200.4μg.mL-1范围内线性良好(r=0.9998),定量限为5 ng(以雷尼替丁计)。结论:本方法简便、灵敏、专属性好、结果准确,适用于枸橼酸铋雷尼替丁及其片剂中雷尼替丁含量的测定。
Objective: To establish a HPLC method for the determination of ranitidine bismuth citrate and its tablets. Methods: The column was InertsilODS-3 (4.6 mm × 150 mm, 5 μm). Phosphate buffer (taking 6.8 mL of phosphoric acid for 1900 mL, adding 8.6 mL of 50% sodium hydroxide solution, adding water to 2000 mL, Phosphoric acid or 50% sodium hydroxide solution to adjust the pH to 7.10 ± 0.05) -acetonitrile (98: 2) and phosphate buffer-acetonitrile (78:22) .min-1, detection wavelength of 230 nm, column temperature of 35 ℃; external standard method. Results: The method showed a good linearity (r = 0.9998) in the range of 2.5 ~ 200.4μg.mL-1 with a limit of quantification of 5 ng (calculated as ranitidine). Conclusion: The method is simple, sensitive, specific and accurate. It is suitable for the determination of ranitidine in bismuth citrate and its tablets.