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作 者:李磊[1] 陈小陆[2] 何小敏[2] 吴喜英[2]
机构地区:[1]广州市中山大学附属第一医院黄埔院区,510700 [2]广州市中山大学附属第一医院药学部,510700
出 处:《中国实用医药》2009年第29期19-20,共2页China Practical Medicine
摘 要:目的建立HPLC测定盐酸雷尼替丁胶囊含量的方法,以控制该制剂的质量。方法色谱柱为Kromasil C18柱(4.6 mm×250 mm,5μm);流动相为甲醇-10 mmol/L磷酸二氢钾溶液(内含0.1%三乙胺)(50:50);流速:1.0 ml/min;检测波长:320 nm,进样量:20μl。结果标准曲线的线性范围为0.5~20 mg/L(r=0.999 8,n=8),平均回收率为100.2%,RSD为1.38%。结论本方法准确、简单,可用于盐酸雷尼替丁胶囊的含量测定。Objective To establish a HPLC method to measure the content of ranitidine hydrochloride capsules. Methods A Kromasil C 18 column (4. 6 mm × 250 mm,5 μm)was adopted. Mobile phase was a mixture of methanol and 10 mmol/Lpotassium dihydrogen phosphate buffer( including 0. 1% triethylamine)( 50: 50 ). The flow rate was 1.0 ml/min. The detection wavelength was at 320 nm. Results The assay procedure was shown to produce linear calibration curves over the range of 0. 5 mg/L to 20 mg/Lof ranitidine hydrochloride( r = 0. 999 8, n = 8). The recovery of the assay was 100. 2%, RSD was 1.38%. Conclusion The method is found to be preciseand simple. It can be used to determine the content of ranitidine hydrochloride capsules.
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