吡哌酸有关物质检查方法的研究

Deternination of the related substances in pipemidic acid

目的:采用HPLC法测定吡哌酸有关物质。方法:采用XDS-C18(150 mm×4.6 mm,5μm)色谱柱,流动相为枸橼酸癸烷磺酸钠溶液(取枸橼酸5.7 g、癸烷磺酸钠1.7 g,加水溶解并稀释至1 000 ml)-乙腈-甲醇(60∶20∶20),流速:1 ml/min,检测波长:275 nm,柱温:30℃,进样量:20μl。结果:吡哌酸在0.062 7～3.760 8μg/ml浓度范围内线性关系良好(r=1.000 0),最小检出限为0.04%。结论:本方法专属性强、灵敏度高、准确度和重复性好,方法简便,可作为吡哌酸有关物质的检测方法。

Objective： To establich a HPLC for the deternination of the related substances in pipemidic acid.Metheds： XDS-C18（150 mm×4.6 mm,5 μm） column was used.The mobile phase consiteel of a mixture of citric acid and sodium decanesulphonate solution（Dissolve 5.7 g of critic acid and 1.7 g of sodium decanesulphonate in 1 000 ml of water）-acetonitrile-methanol（60∶20∶20）.The flow rate was 1.0 ml/min.The detection wavelength is 275 nm.The column temperature of the column was 30 ℃.The injection volume was 20 μl.Results ：The calibration curue was linear in the range of 0.062 7～3.760 8 μg/ml for pipemidic acid（r=1.000 0）.The detection Limit was 0.04%.Conclusion：The seleitine and accurate methad can be used for the quality control of pipemidic acid.