HPLC法测定盐酸帕洛诺司琼的含量及有关物质

目的: 建立测定盐酸帕洛诺司琼含量及有关物质的高效液相色谱方法。方法: 采用Alltima C₁₈色谱柱(250 mm×4.6 mm,5 μm),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至3.0)-乙腈(60∶40)为流动相,流速1.5 mL·min^-1,检测波长分别为242nm(含量)与 210 nm (有关物质)。结果: 在上述色谱条件下,各中间体及各降解产物均可与盐酸帕洛诺司琼主峰良好分离。HPLC测定的线性范围为10.1~100.9 g· mL^-1,r=0.9999;方法的日内与日间精密度RSD分别为0.51%和0.85%。结论:采用HPLC测定盐酸帕洛诺司琼的含量及有关物质,方法简便,结果准确可靠。

Objective: To establish an RP-HPLC method for determination of the content and the related substances of palonosetron hydrochloride. Methods: The separation was performed on an Alltima C₁₈ column(250 mm×4.6 mm,5 μm),and the mobile phase consisted of 0.02 mol·L^-1 sodium dihydrogen phosphate(containing 0.25% triethylamine and 0.01 mol·L^-1 sodium hexanesulfonate, adjusted the pH to 3.0 with phosphoric acid)-acetonitrile(60∶-40) at the flow rate of 1.5 mL·min^-1.The detection was set at 242 nm(for assay)and 210 nm(for test of related substances).[HTH][STHZ][WTHZ]Results:[HTSS][WTBZ][STBZ]An excellent separation was achieved for palonosetron hydrochloride and its related substances.The assay was validated in the concentration range of 10.1-100.9 g· mL^-1(r=0.9999).The precision in a day and during the days were 0.51% and 0.85%. Conclusion: The method developed is successfully used to determine palonosetron hydrochloride and its related substances.