HPLC法同时测定氯雷他定糖浆中氯雷他定和苯甲酸钠的含量

Simultaneous determination of loratadine and sodium benzoate in Loratadine Syrup by HPLC

目的：采用高效液相色谱法同时测定氯雷他定糖浆中氯雷他定和苯甲酸钠的含量。方法采用 Agilent Zorbax Eclipse XDB - pheny（4.6 mm ×150 mm，3.5μm）色谱柱，以甲醇-乙腈-0.05 mol·L^ -1磷酸二氢钾溶液（用磷酸调节 pH 值至3.5）（15：10：75）为流动相；流速：1 mL·min ^-1，检测波长：254 nm，柱温：30℃。结果氯雷他定在40.18～140.62μg·mL^ -1范围内线性关系良好（r =0.9999），苯甲酸钠在39.94～139.78μg·mL -1范围内线性关系良好（r =0.9999），平均回收率分别为100.05%（RSD =0.52%，n =6）、100.18%（RSD =0.36%，n =6）。结论本方法简便、快速、准确，重复性好，可用于氯雷他定糖浆中氯雷他定和苯甲酸钠的含量测定。

Objective To establish an HPLC method for the simultaneous determination of loratadine and sodium ben-zoate in Loratadine Syrup. Methods Agilent Zorbax Eclipse XDB - pheny column（4. 6 mm × 150 mm,3. 5 μm）was a-dopted with methanol - acetonitrile - 0. 05 mol·L - 1 potassium dihydrogen phosphate（pH was adjusted to 3. 5 by phos-phate）（15：10：75）as mobile phase. The flow rate was 1. 0 mL·min^ - 1 ,the detection wavelength was 254 nm and the col-umn temperature was 30 ℃ . Results The linear ranges were 40. 18 ～ 140. 62 μg·mL - 1 for loratadine（r = 0. 999 9）and 39. 94 ～ 139. 78 μg·mL - 1 for sodium benzoate（r = 0. 999 9）,the average recoveries were 100. 05%（RSD = 0. 52% ,n =6）and 100. 18%（RSD = 0. 36% ,n = 6）,respectively. Conclusion The method was simple,sensitive and accurate,and it can be applied to the concentration determination of loratadine and sodium benzoate in Loratadine Syrup.