氯雷他定片含量测定方法的改进

Improvement of content determination of Loratadine Tablets

目的改进氯雷他定片的含量测定方法。方法采用Kromasil C18色谱柱(4.6mm×150mm,5μm),柱温为室温,流动相为磷酸盐缓冲液(取磷酸氢二钾0.57g,加水800mL使溶解,用磷酸调节pH值为6.0,加水至1000mL)-甲醇(20∶80),检测波长247nm,流速为1.0mL/min,进样体积为10μL,进样浓度为16μg/mL。结果降低进样浓度及流动相中盐的比例后,氯雷他定色谱峰型对称,符合系统适应性要求,进样量在0.03196～0.63920μg范围内与峰面积有良好的线性关系(r=0.99999,n=6),高、中、低3种浓度的平均加样回收率为99.4%(RSD=0.58%,n=9)。结论该法结果准确可靠、重现性好,有利于延长泵及色谱柱的使用寿命,可作为氯雷他定片的含量测定方法。

Objective To improve the method for the content determination of Loratadine Tablets. Methods The determination was performed on a Kromasil C18 column （4.6 mm×150 mm, 5 μm） at ambient temperature; the mobile phase was phosphate buffer solution （dissolved 0.57 g of dipotassium hydrogen phosphate in 800 mL of water, adjusted pH 6.0 with phosphoric acid, added water into 1 000 mL）-methanol（20：80）; the detective wavelength was 247 nm; the flow rate was 1.0 mL/min; the injection volume was 10 μL; the injection concentration was 16 μg/mL. Results After reduced injection concentration and changed the ratio of phosphate buffer in the mobile phase, the peak shape of Loratadine was symmetrical and met the standards of system adaptability. The method showed a good linear relation over the range of 0.031 96-0.639 20 μg （r = 0.999 99, n = 6）. The average recovery was 99.4% （RSD = 0.58%, n = 9）. Con- clusion This method is accurate, reliable, reproducible and extends the life of pump and column. It can be used in the quality control of Loratadine tablets.