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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,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10.1~100.9mg.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 a HPLC method for the determination of palonosetron hydrochloride and its related substances. METHODS: Alltima C18 column (250 mm × 4.6 mm, 5 μm) was used in this study. 0.02 mol·L -1 sodium dihydrogen phosphate solution (containing 0.25% triethylamine and 0.01 mol·L -1 hexanesulfonate, The pH was adjusted to 3.0 with phosphoric acid - acetonitrile (60:40) as the mobile phase and the flow rate was 1.5 mL.min-1. The detection wavelength was 242 nm (content) and 210 nm (related substances). Results: Under the above chromatographic conditions, each intermediate and each degradation product can be well separated from the main peak of palonosetron hydrochloride. The linear range of HPLC was 10.1 ~ 100.9 mg.mL-1, r = 0.9999. The intra-and inter-day RSD of the method was 0.51% and 0.85%, respectively. Conclusion: HPLC method for the determination of palonosetron hydrochloride and related substances, the method is simple and accurate and reliable.