RP-HPLC法测定左旋硫酸沙丁胺醇水凝胶骨架缓释片中主药含量

Determination of levosalbutamol sulfate in hydrogel matrix sustained release tablets by RPHPLC

目的建立测定左旋硫酸沙丁胺醇水凝胶骨架缓释片中左旋硫酸沙丁胺醇质量分数的方法。方法采用反相高效液相色谱法,色谱柱为Agilent-C18柱,流动相为质量浓度11.04 g/L的Na H2PO4水溶液（pH值3.10±0.05）（A）-甲醇（B）（体积比85∶15）,流速为1.0 m L/min,检测波长为276 nm,柱温为40℃。结果左旋硫酸沙丁胺醇的质量浓度在7.812 5~250.00μg/m L范围内具有良好的线性关系（r=1）,平均回收率为99.3%,RSD为0.93%（n=9）。结论本方法可用于左旋硫酸沙丁胺醇水凝胶骨架缓释片的质量分数测定。样品溶液制备方法对其他水凝胶剂型药物质量分数测定有一定参考意义。

Objective To establish an HPLC method for the determination of levosalbutamol in hydrogel matrix sustained release tablets. Methods RP-HPLC was adopted to determine levosalbutamol using an Agilent-C18 column with an isocratic elution system of aqueous solution of sodium dihydrogen phosphate（ pH is 3. 10 ± 0. 05）（ A）-methanol（ B）（ 85∶ 15）,while the flow rate was 1. 0 m L/min,the detection wavelength was 276 nm and the column temperature was maintained at 40 ℃. Results The linearity was good within the range of 7. 812 5- 250. 00 μg / m L（ r = 1）. The average recovery was 99. 3% and RSD was0. 93%（ n = 9）. Conclusion The method could be used to determine the content of levosalbutamol sulphate in hydrogel matrix sustained release tablets. The method of preparing testing samples has some significance for other drugs＇ assay in hydrogel formulations.