HPLC法测定氯雷他定糖浆中依地酸二钠的含量  

Determination of Edetate Disodium in Loratadine Syrup by HPLC

作　　者：柯跃鸿 骆仁红 孙嘉嘉 崔文霞 KE Yue-hong;LUO Ren-hong;SUN Jia-jia;CUI Wen-xia(Fujian Pacific Pharmaceutical Co.,Ltd.,Quanzhou 362211,China;Prinbury Biopharm R&D(Shanghai)Co.,Ltd.,Shanghai 201210,China)

机构地区：[1]福建太平洋制药有限公司,福建泉州362211 [2]普霖贝利生物医药研发(上海)有限公司,上海201210

出　　处：《海峡药学》2022年第6期54-56,共3页Strait Pharmaceutical Journal

摘　　要：目的建立氯雷他定糖浆中依地酸二钠(EDTA·2Na)含量检测的HPLC法。方法色谱柱为Xtimate C_(18)(4.6×250 mm,5μm),流动相A为pH 2.4的磷酸二氢铵缓冲液-甲醇(95∶5),流动相B为甲醇,梯度洗脱,检测波长为258 nm,柱温为35℃,流速为0.8 mL·min^(-1),进样量为25μL。结果EDTA·2Na浓度在12.56~37.68μg·mL^(-1)水平范围内线性关系良好(r=0.99997);平均回收率为100.31%(RSD为0.39%,n=9);溶液稳定性良好。结论本方法简便快捷、准确、专属性高、重复性好,可用于氯雷他定糖浆中依地酸二钠的含量测定。OBJECTIVE To establish an HPLC method for content determination of edetate disodium(EDTA·2Na)in Loratadine Syrup.METHODS The chromatographic column was Xtimate C_(18)(4.6×250 mm,5μm).The mobile phase A was the mixture of ammonium dihydrogen phosphate buffer in methanol(95∶5,pH 2.4).The mobile phase B was methanol.During gradient elution,the detection wavelength was 258 nm,the column temperature was 35℃,the flow rate was 0.8 mL·min^(-1) and the sample volume was 25μL.RESULTS The concentration of EDTA·2Na had a good linear relationship in the range of 12.56~37.68μg·mL^(-1)(r=0.99997).The average recovery rate was 100.31%with RSD of 0.39%(n=9).Good solution stability.CONCLUSION A simple and rapid method with high accuracy,specificity and reproducibility was established for the determination of EDTA·2Na in Loratadine Syrup.

关 键 词：HPLC 氯雷他定糖浆 依地酸二钠 含量测定 

分 类 号：R927[医药卫生—药学]