【摘要】 目的以高效液相色谱法测定盐酸西替利嗪咀嚼片含量及有关物质。方法采用Luna C18柱(250 mm×4.60 mm,5μm);以甲醇-0.05 mol.L-1乙酸铵溶液(73∶27)为流动相;流量:1.0 ml.min-1;检测波长:230 nm;柱温:室温。结果本方法灵敏、准确、专属行强。线性范围:9.48~56.88 mg.L-1(r=0.9999,n=6);方法回收率为99.78%,RSD=0.53%。结论建立的定量方法专属性强,可以克服辅料对测定的干扰,用于盐酸西替利嗪咀嚼片的质量控制。更多还原

【Abstract】 AIM To develop a HPLC method for the determination of cetirizine hydrochloride and related substances.METHOD The chromatographic analysis was performed on a Luna ODS column（250 mm×4.60 mm,5 μm）.The mobile phase was consisted of methanol-0.05 mol·L^-1 ammonium acetate（73∶27）.The flow rate was 1.0 ml·min^-1 and the detection wavelength was at 230 nm.RESULT The method was validated,and the excipients did not interfere with the determination of cetirizine hydrochloride.The standard curve was linear within the range of 9.48～56.88 mg·L^-1,r=0.999 9.The average recovery was 99.78%（RSD=0.53%）.CONCLUSION This method was simple,accurate,which may be used for the quality control of cetirizine hydrochloride chewable tablets.更多还原