反相高效液相色谱法测定盐酸左西替利嗪片的含量

Determination of levocetirizine hydrochloride tablets by RP-HPLC

目的建立RP-HPLC法测定盐酸左西替利嗪片含量的方法,同时考察全国数批盐酸左西替利嗪片的含量。方法采用Xtimate C18色谱柱（250 mm×4.6 mm,5μm）,流动相为四氢呋喃-甲醇-磷酸盐溶液（磷酸二氢钠3.1 g,用水溶解稀释至1 000 mL,用磷酸调节pH值至2.9）（5.5：49.5：45）;检测波长为231 nm,流速为1.0 mL·min-1,柱温为35℃。结果盐酸左西替利嗪在25.74~257.4μg·mL-1（r=0.999 9）内有良好的线性关系,低、中、高浓度平均加样回收率分别为100.1%、100.2%、102.1%（RSD分别为0.24%、0.20%、0.47%）（n=3）。结论该方法简便、准确、重复性好,可有效地控制药品质量。

Objective To establish an HPLC method for determination of levocetirizine hydrochloride tablets and to inspect the content of batches of levocetirizine hydrochloride tablets in the country. Methods Xtimate C18 （250 mm × 4.6 mm, 5 μm） column was used. The mobile phase was tetrahydrofuran-methyl alcohol-phosphate solu- tion （5.5 ： 49.5 ： 45）. The detection wavelength was 231 nm, the flow rate was 1.0 mL · min 2, and the column temperature was 35℃. Results The linearity for levocetirizine hydrochloride was 25.74 - 257.4 μg · mL- 1 （r ： 0.999 9）. The average recoveries were 100.1%, 100.2%, 102.1% （RSDs were 0.24%, 0.20%, 0.47%）. Conclusion The method is convenient, accurate and simple, which can be used to control the quality of levocetirizine hydrochloride tablets.