目的建立盐酸帕洛诺司琼注射液含量测定的高效液相色谱方法。方法采用Alltima C₁₈色谱柱(4.6 mm×250 mm,5μm),以0.02 mol·L^-1磷酸二氢钠溶液(含0.25%的三乙胺与0.01 mol·L^-1己烷磺酸钠,用磷酸调节pH值至3.0)-乙腈(40∶60)为流动相;检测波长为254 nm,流速为1.5 mL·min^-1。结果线性范围为10.3～103.1 mg·L^-1,r=0.999 9;平均回收率为100.4%,RSD为0.95%(n=9)。结论本方法简便、可靠,可用于盐酸帕洛诺司琼注射液的含量测定。

OBJECTIVE To establish a HPLC method for the determination of palonosetron hydrochloride for injection.METHODS The separation was performed on a Alltima C₁₈ column(4.6 mm×250 mm,5 μm)with the mobile phase consisting of 0.02 mol· L^-1 sodium dihydrogen phosphate(contain 0.25% triethylamine and 0.01 mol·L^-1 sodium hexanesulfonate,adjust the pH to 3.0 with phosphoric acid)-acetontrile(40∶60).The detection wavelength was 254 nm.RESULTS The method was proved to be linear in the range of 10.3～103.1 mg·L^-1,the regression coefficient was 0.999 9.The recovery of method was 100.4%(RSD 0.95%,n=9).CONCLUSION The method is simple,reliable and suitable for the determination of palonosetron hydrochloride for injection.