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盐酸左西替利嗪口腔崩解片的含量及有关物质测定
引用本文:张理星,孙建合,朱啸风,崔志红.盐酸左西替利嗪口腔崩解片的含量及有关物质测定[J].中国药业,2008,17(12):47-48.
作者姓名:张理星  孙建合  朱啸风  崔志红
作者单位:鲁南制药集团股份有限公司,山东临沂276006
摘    要:目的建立测定盐酸左西替利嗪口腔崩解片含量及有关物质的方法。方法色谱柱为Alltima C18柱(250mm×4.6mm,5μm),流动相为甲醇-0.02mol/L磷酸二氢钾溶液(70:30),检测波长230nm,流速1.0mL/min。结果盐酸左西替利嗪质量浓度在0.08-0.12g/L内与峰面积线性关系良好(r=0.9992),平均回收率为99.8%,RSD=0.56%(n=9)。结论该法操作简便、灵敏度高、重现性好,结果准确可靠。

关 键 词:高效液相色谱法  盐酸左西替利嗪  含量测定  有关物质

Determination of Levocetirizine Hydrochloride and Its Related Substances in Levocetirizine Hydrochloride Orally Disintegrating Tablets by HPLC
Zhang Lixing,Sun Jianhe,Zhu Xiaofeng,Cui Zhihong.Determination of Levocetirizine Hydrochloride and Its Related Substances in Levocetirizine Hydrochloride Orally Disintegrating Tablets by HPLC[J].China Pharmaceuticals,2008,17(12):47-48.
Authors:Zhang Lixing  Sun Jianhe  Zhu Xiaofeng  Cui Zhihong
Institution:( Lunan Pharmaceutical Group Co., Ltd., Linyi, Shandong, China 276006)
Abstract:Objective To establish a HPLC method for determining the content and related substances of Levocetirizine Hydrochloride Orally Disintegrating Tablets. Methods Alltima C18 column(250 mm×4.6 mm,5μm) was used. The mobile phase consisted of methanol -0. 02 moL/L potassium phosphate monobasic solution(70:30). The detection wavelength was at 230 nm. The flow rate was 1.0 mL/min. Results The standard curve of levocetirizine hydrochloride was linear in the range of 0.08-0. 12 g/L(r=0.999 2).The average recovery rate was 99. 8% , RSD =0. 56% ( n =9). Conclusion This method is simple, sensitive, reproducible and accurate.
Keywords:HPLC  levocetirizine Hydrochloride  quantitative determination  related substances
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