HPLC法测定盐酸帕诺洛司琼注射液的有关物质

Determination of related substances in Palonosetron Hydrochloride Injection by HPLC

目的建立高效液相色谱法测定盐酸帕诺洛司琼注射液的有关物质。方法氰基硅烷键合硅胶柱(200×4.6mm),以醋酸铵溶液(取醋酸铵5.0g,加稀醋酸500mL使溶解,加三乙胺10mL,加水稀释成1000mL)-乙腈(75∶25)为流动相;柱温:30℃;流速:1mL.min-1;检测波长:265nm。结果主成分与有关物质及各降解成分完全分离,总杂质量均低于限度要求。结论该方法专属性强、准确度好、灵敏度高,适合盐酸帕诺洛司琼注射液有关物质的测定。

OBJECTIVE To establish an HPLC method for determination of related substances in Palonosetron Hydrochloride Injection. METHODS A Hypersil BDS Cyano column was used with the mobile phase of Ammonium acetate solution （Ammonium acetate 5.0g was dissolved by dilute acetic acid 500mL,add triethy lamine 10mL, add water to 1000mL）--acetonitrle（75 ： 25） ;the column was 30℃ ;the flow rate was 1mL.min^-1 and the detection wavelength was set at 265nm. RESULTS Related substances and degraded substances were completely separated from main constituent;Total impurities were below the limits. CONCLUSION The method was selective,accurate sensitive and it was suitable for determination of related substance in Palonosetron Hydrochloride Injection.