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目的建立百部配方颗粒的HPLC指纹图谱分析方法,为科学评价其质量提供依据。方法采用高效液相色谱法,以AKKZONOBEL Kromasil 100-5 C18(4.6 mm×250 mm,5μm)色谱柱;以乙腈(A)-0.1%(体积分数)磷酸(B)为流动相进行梯度洗脱;检测波长270 nm;流速0.8 ml·min-1;柱温25℃。结果建立了百部配方颗粒的指纹图谱,确定了19个共有峰,10批百部配方颗粒样品相似度均在0.9以上。结论该方法简便、准确、重复性好,能有效地对百部配方颗粒的质量进行评价。
OBJECTIVE To establish HPLC fingerprinting method for one hundred formula particles and provide scientific basis for evaluating its quality. Methods High performance liquid chromatography (HPLC) was performed on an AKKZONOBEL Kromasil 100-5 C18 column (4.6 mm × 250 mm, 5 μm) with gradient elution with acetonitrile (A) -0.1% phosphoric acid (B) ; Detection wavelength was 270 nm; flow rate was 0.8 ml · min-1; column temperature was 25 ℃. Results Fingerprints of 100 formula particles were established and 19 common peaks were identified. The similarity of 10 batches of formula particles was above 0.9. Conclusion The method is simple, accurate and reproducible. It can effectively evaluate the quality of 100 formula particles.