反相高效液相色谱法测定盐酸哌罗匹隆原料药含量

摘要

Objective: To establish a RP-HPLC method for the determination of concentration of perospi-rone hydrochloride and its related substances. Methods: The HPLC condition was as follows; a C_(18) column (250 mm × 4. 6 mm, 5 μm) with a column temperature at 30 ℃ , an eluate of 1. 02% potassium dihydrogen phosphate and 0.4% 1-Heptanesulfonic acid, pH =3.0 [adjusted with phosphoric acid-acetonitrile (60:40)] , a flow rate of 1. 0 mL·min~(-1) and detection at 230nm. Results: Perospirone hydrochloride was compeletely separated from impurities. The calibrated linear curve of perospirone was within 37. 1～111. 4 μg·mL~(-1) with the correlation coefficient of 0. 999 9. The average recovery was 100. 9% (RSD = 1.3%). Conclusion: This RP-HPLC method is accurate, reliable, and applicable for the quality control of perospirone hydrochloride and its related substances.%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 C_(18)柱(250 mm×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.