HPLC法测定枸橼酸铋雷尼替丁及其片剂中雷尼替丁的含量

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Inertsil^® ODS-3 (4.6 mm×150 mm,5 μm);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2.5～200.4 μg·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 an HPLC method for the determination of ranitidine in ranitidine bismuth citrate and its tablets. Methods: Inertsil^® ODS-3 column (4.6 mm×150 mm,5 μm) was adopted with gradient elution,phosphate buffer (accurately add phosphoric acid 6.8 mL and 50% sodium hydroxide solution 8.6 mL into approximately 1900 mL of water,and mix.Dilute with water to 2000 mL.Adjust pH 7.10±0.05 with 50% sodium hydroxide solution or phosphoric acid)-acetonitrile (98:2) as the mobile phase A and phosphate buffer-acetonitrile (78:22) as the mobile phase B at the flow rate of 1.2 mL·min^-1,the detective wavelength was 230 nm and the temperature of column was 35 ℃. Results: The linear range of ranitidine was 2.5-200.4 μg·mL^-1(r=0.9998).The limit of quantification was 5 ng. Conclusion: The method is simple,sensitive,selective,accurate and can be used for the determination of ranitidine in ranitidine bismuth citrate and its tablets.

[1] ZUO Xiu-li(左秀丽),XIE Yi-kui(谢宜奎),CHEN Shi-bao(陈士葆).The new anti-ulcer drug—Ranitidine Bismuth Citrate (抗溃疡病新药——雷尼替丁枸橼酸铋).Chin J New Drugs Clin Remed (中国新药与临床杂志),1995,18 (3):169
[2] WANG You-min(王友敏).The treatment of peptic ulcer (消化性溃疡的治疗).China Pract Med (中国实用医药),2010,5 (14):69
[3] Drug Specifications Promulgated by State Drug Administration (国家药品标准).WS₁-(X-193)-2004Z
[4] Drug Specifications Promulgated by State Drug Administration (国家药品标准).WS₁-(X-192)-2004Z
[5] USP 32-NF 27.2009.3475
[6] CHEN Jie(陈杰),ZHENG Zi-dong(郑子栋),LI Jie(李洁),et al.The quality analysis for the ranitidine hydrochloride capsules (盐酸雷尼替丁胶囊的质量分析).Chin J Pharm Anal (药物分析杂志),2010,30 (11):2160