RP-HPLC法测定盐酸左西替利嗪咀嚼片中的有关物质

Determination of Related Substance in Levo-cetirizine Hydrochloride Chewable Tablet by RP-HPLC

目的：建立测定盐酸左西替利嗪咀嚼片中有关物质的方法。方法：采用反相高效液相色谱法。色谱柱为Venusil XBP-CN，流动相为乙腈-0.05 mol/L磷酸二氢钠溶液（以磷酸调节pH至3.0）（60∶40，V/V），检测波长为230 nm，流速为1.0 ml/min，柱温为25℃，进样量为20μl。结果：盐酸左西替利嗪与有关物质分离度良好；盐酸左西替利嗪检测质量浓度线性范围为1.2～2.8μg/ml（r＝0.9999）；定量限和检测限分别为1.4、0.3 ng/ml；精密度、稳定性、重复性试验的RSD＜1％；加样回收率为96.3％～105.0％，RSD＝1.7％（n＝9）；样品中有关物质含量≤0.17％。结论：该方法操作简单，灵敏度高，重复性好，结果准确、可靠，可用于盐酸左西替利嗪原料药及其制剂的有关物质测定。

OBJECTIVE：To establish a method for the determination of related substances in Levo-cetirizine hydrochloride chewable tablet. METHODS：RP-HPLC was performed on the column of Venusil XBP-CN with mobile phase of acetonitrile-0.05 mol/L Sodium dihydrogen phosphate solution（pH value adjusted to 3.0 by phosphoric acid）（60∶40,V/V）at a flow rate of 1.0 ml/min, the detection wavelength was 230 nm,column temperature was 25 ℃,and volume injection was 20 μl. RESULTS：Levo-cetirizine hydrochloride chewable tablet showed good separation with related substances;the linear range of levo-cetirizine hydrochloride was 1.2-2.8 μg/ml（r=0.999 9）;the quantification limit and detection limit was 1.4 ng/ml and 0.3 ng/ml,respectively;RSDs of preci-sion,stability and reproducibility tests were lower than 1%;recovery was 96.3%-105.0%（RSD=1.7%,n=9）;the contents of re-lated substances were no more than 0.17%. CONCLUSIONS：The method is simple,sensitive,reproducible,accurate and reli-able,and can be used for the determination of related substances in Levo-cetirizine hydrochloride chewable tablet.