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目的:建立反相高效液相色谱法测定磷酸咯萘啶注射液含量及有关物质。方法:色谱柱为Phenomenex Luna C18柱(250mm×4.6 mm,5μm),以乙腈-0.05 mol.L-1磷酸二氢钾溶液(含0.1%三乙胺,用磷酸调节pH至3.0)(15∶85)为流动相,流速1.0 mL.min-1,检测波长为278 nm,结果:磷酸咯萘啶测定的线性范围为40.1～120.4μg.mL-1,r=1.000;最低检测限为0.8 ng;低、中、高浓度的平均回收率为99.5%,99.6%,99.5%(n=3);RSD分别为0.35%,0.30%,0.42%。日内和日间精密度的RSD分别为0.33%和0.20%。结论:本方法简便、快速,结果准确、可靠。
Objective: To establish an RP-HPLC method for the determination of pyronaridine phosphate injection and related substances. METHODS: The column was a Phenomenex Luna C18 column (250 mm × 4.6 mm, 5 μm) with acetonitrile-0.05 mol·L-1 potassium dihydrogen phosphate solution containing 0.1% triethylamine adjusted to pH 3.0 with phosphoric acid (15: 85) as the mobile phase at a flow rate of 1.0 mL · min-1 with a detection wavelength at 278 nm. The results showed that the linear range of the pyronaridine phosphate was 40.1-120.4 μg · mL-1, r = 1.000. The minimum detection limit was 0.8 ng The average recoveries of low, middle and high concentrations were 99.5%, 99.6% and 99.5% (n = 3), respectively. The RSDs were 0.35%, 0.30% and 0.42%, respectively. The RSDs for intra-day and inter-day precision were 0.33% and 0.20%, respectively. Conclusion: The method is simple, rapid, accurate and reliable.