| 引用本文: | 唐立超,郭伟斌,郑淑凤,黄剑英,李玲玲.HPLC测定氯雷他定的含量及其有关物质[J].中国现代应用药学,2014,31(8):994-997. |
| TANG Lichao,GUO Weibin,ZHENG Shufeng,HUANG Jianying,LI Lingling.Determination of Content and Related Substances of Loratadine by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2014,31(8):994-997. |
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| 摘要: |
| 目的 建立高效液相色谱法测定氯雷他定含量及其5种有关物质。方法 采用Agilent TC-C18色谱柱(250 mm×4.6 mm，5 μm)，以乙腈-2%冰醋酸溶液为流动相，梯度洗脱，流速为1.0 mL·min?1，检测波长为276 nm。结果 氯雷他定及其5种杂质分离良好。氯雷他定、地洛他定、N-甲基地洛他定、三环酮、杂质F、杂质I分别在3.2~106.7，0.97~ 58.3，0.59~35.5，0.58~34.5，0.59~35.4，0.82~49.3 μg·mL?1内线性关系良好(r=0.999 4~0.999 9)。结论 本方法准确、灵敏、可靠，可用于氯雷他定原料药和制剂的质量研究和质量控制。 |
| 关键词: 氯雷他定 有关物质 含量测定 高效液相色谱法 |
| DOI： |
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| 基金项目:厦门市重大科技项目(3502Z20121035) |
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| Determination of Content and Related Substances of Loratadine by HPLC |
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TANG Lichao, GUO Weibin, ZHENG Shufeng, HUANG Jianying, LI Lingling
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Xiamen Institue for Drug Control, Xiamen 361012, China
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| Abstract: |
| OBJECTIVE To establish an HPLC method for the determination of the content and related substances of loratadine. METHODS Agilent TC-C18 column was used, the mobile phase consisted of acetonitrile-2% acetic acid solution, gradient elution. The flow rate was 1.0 mL·min?1. The detection wavelength was 276 nm. RESUTLS Loratadine and its impurities could be separated with a good resolution. Loratadine, deslorata, N-methyldesloratadine, tricyclic ketone, impurity F and I were linear in the range of 3.2-106.7, 0.97-58.3, 0.59-35.5, 0.58-34.5, 0.59-35.4, 0.82-49.3 μg·mL?1(r=0.999 4-0.999 9). CONCLUSION With good accuracy, sensitivity and reliability, the method can be applied to quality research and quality control of loratadine and its preparations. |
| Key words: loratadine related substances content determination HPLC |
