高效液相测定聚甲酚磺醛栓剂中四种相关物质的含量

目的建立用HPLC法测定聚甲酚磺醛栓剂中四种相关物质的含量。方法色谱柱为DiamonsilC18柱（150mm×4．6mm，5um），检测波长为265nm，流动相为1％的乙酸铵溶液：甲醇（90：10）条件下测定m-甲酚-4，6-二磺酸铵、m-甲酚-4-磺酸铵，m-甲酚-6-磺酸铵；在捡测波长为280nm，以1％的乙酸铵溶液：甲醇（70：30）为流动相下聚甲酚磺醛二聚体铵，流速均为1．0mL／min，进样量5uL，柱温30℃。结果间甲酚-4，6-二磺酸铵、间甲酚-4-磺酸铵、间甲酚-6-磺酸铵与聚甲酚磺醛二聚体铵分别在0．0402-0．9636μg、0．0567-1．3608μg、0．0526-1．2624μg、0．0572-1．143μg范围内线性关系良好。间甲酚-4，6-二磺酸铵的线性方程为：Y=89806X＋615，r=0．9999；间甲酚-4-磺酸铵的线性方程为：Y=112889X＋1798，r=0．9997；间甲酚-6-磺酸铵的线性方程为：Y=136254X-2164，r=0．9997；聚甲酚磺醛二聚体铵线性方程为Y=259112X-3650，r=0．9994。各组分精密度，稳定性，重复性和回收率RSD均〈3％。结论该法准确性和重复性好，可用于聚甲酚磺醛栓剂的质量控制。

Determination of Four Components in Pol/cresulenVaginal Suppositories by HPLC

Objective To develop an HPLC method for the content determination of determination of four components in policresulen vaginal suppositories. Methods Using high performance liquid chromatography （HPLC） method, a Diamonsil C18 （150mmx4.6mm, 5μm） column was used, with 1% ammonium acetate solution -methanol （90 ： 10） and 1% ammonium acetate solution -methanol （70 ： 30） as mobile phase. The mobile phase flow rate was 1.0 mL/min. The detector wavelength was set at 265nm and 280nm the column temperature was 30℃. Results Four kinds of composition content curve was linear over the range of 0.0402-0.9636μg, 0.0567-1.3608μg, 0.0526-1.2624μg, 0.0572-1.143μg （r=0.9999,r=0.9997,r=0.9997,r=0.9994）. Stability, repeatability and recovery of Components RSD are less than 3%. Conclusion The proposed method is convenient, economical and accurate with good reproducibility, and can be used to evaluate the quality of policresulen vaginal suppositories