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目的:建立了反相高效液相色谱法测定盐酸哌罗匹隆原料药含量及有关物质,为哌罗匹隆原料药的含量和有关物质测定提供检测方法,制定质控标准。方法:色谱柱为依利特Hypersil ODS C18柱(250mm×4.6 mm,5μm),流动相为磷酸盐缓冲液(含1.02%磷酸二氢钾和0.4%庚烷磺酸钠,用磷酸调pH3.0)-乙腈(60∶40),流速为1.0 mL.min-1;检测波长为230 nm;柱温为30℃。结果:主峰能与相邻杂质峰较好分离,哌罗匹隆的浓度在37.1~111.4μg.mL-1范围内线形关系良好,相关系数为0.999 9。结论:该法简便、准确、专属性好,可以用于盐酸哌罗匹隆原料药的含量测定。
OBJECTIVE: To establish a reversed-phase high performance liquid chromatography (RP-HPLC) method for the determination of the content and related substances of pipereline hydrochloride drug substance, to provide a detection method for the determination of the content and related substances of piperopirone drug substance, and to establish the quality control standards. METHODS: The column was Elixir Hypersil ODS C18 column (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of phosphate buffer (containing 1.02% potassium dihydrogen phosphate and 0.4% sodium heptanesulfonate, adjusted to pH 3.0 with phosphoric acid ) -acetonitrile (60:40) at a flow rate of 1.0 mL.min-1. The detection wavelength was 230 nm. The column temperature was 30 ℃. Results: The main peak could be separated from the adjacent impurity peaks. The concentration of piperopelone was linear in the range of 37.1 ~ 111.4μg.mL-1 with a correlation coefficient of 0.999 9. Conclusion: The method is simple, accurate and specific and can be used for the determination of the drug substance of piperpirone hydrochloride.