制剂药品中盐酸雷尼替丁含量测定方法的优化

摘要

A monitoring method with HPLC detection of ranitidine amount in medicine was set up. The result was gained by detecting the ranitidine chromatographic peak of the sample with HPLC in KH2PO4 solution-acetonitrile by isocratic elution and quantited by the standard curve. The concentration of ranitidine was linear with chromatographic peak area in the range of 5-500μg/mL with the correlation coefficent more than 0.999 9. RSD was 0.85%(n=6)and the recovery rate was (100±2)%. The method was handy operation, lower consumption and dependable, which can be used to detect the content of tablet and capsule of ranitidine.%建立高效液相色谱仪测定盐酸雷尼替丁制剂含量的检测方法。采用磷酸盐缓冲液与乙腈等比混合的流动相等度洗脱，于314 nm检测，外标法定量。盐酸雷尼替丁质量浓度在5～500μg/mL范围内与色谱峰面积线性相关，相关系数大于0.9999。6次测定结果的相对标准偏差为0.85%，加标回收率为(100±2)%。该法操作简便、清洁高效、准确可靠，可用于盐酸雷尼替丁片和胶囊含量的测定。