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目的建立对羟基苯甲酸甲酯钠的含量测定及有关物质检查方法。方法采用高效液相色谱法,色谱柱为Shim-packVP-ODS C18柱(250 mm×4.6 mm,5μm),以甲醇-1%醋酸溶液(60∶40)为流动相,流速1.0 mL.min-1,柱温35℃,波长254 nm。结果对羟基苯甲酸甲酯与各主要杂质及强制破坏产生的降解产物的杂质峰均分离良好,对羟基苯甲酸甲酯在21.64～194.8μg.mL-1内与峰面积呈良好线性关系,r=1.000,回收率为99.5%(RSD=0.64%,n=9),最低检出限为0.214 4 ng;供试品溶液在24 h内稳定。结论本法专属性强,准确、灵敏,方法可靠,可用于对羟基苯甲酸甲酯钠的含量测定和有关物质检查。
Objective To establish a method for the determination of sodium methylparaben and related substances. Methods High performance liquid chromatography (HPLC) was performed on a Shim-pack VP-ODS C18 column (250 mm × 4.6 mm, 5 μm) with methanol-1% acetic acid solution 60:40 as mobile phase at a flow rate of 1.0 mL · min- 1, column temperature 35 ℃, wavelength 254 nm. Results Methylparaben was well separated from the major impurities and the impurity peaks of the degradation products. The methylparaben showed a good linear relationship with the peak area in the range of 21.64-194.8μg.mL-1, and r = 1.000, the recovery was 99.5% (RSD = 0.64%, n = 9). The minimum detectable limit was 0.214 4 ng. The test solution was stable within 24 h. Conclusion This method is specific, accurate, sensitive and reliable. It can be used for the determination of sodium methylparaben and related substances.