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[摘要]
目的 建立复方石韦片的HPLC指纹图谱测定方法,并应用于其制剂过程中的质量控制。方法 采用HPLC法,使用Agilent 5 TC C18(2)色谱柱(250 mm×4.6 mm,5μm),以乙腈-0.2%磷酸水溶液为流动相进行梯度洗脱,体积流量为1.0 mL/min,检测波长为235 nm,柱温为25℃,进样量为10 μL。对14批不同批次的复方石韦片及3批复方石韦片中间体(浸膏、颗粒)样品进行测定。结果 建立了复方石韦片HPLC指纹图谱共有模式,标定了18个共有峰,指认出其中5个色谱峰,各批次间共有峰相对保留时间RSD均<0.3%,批次间相似度>0.990。相同批次的复方石韦片中间体(浸膏、颗粒)及其成品间相似度均>0.990,相关性良好。结论 建立的复方石韦片HPLC指纹图谱方法简便、有效、重复性好,并可应用于其制剂制备工艺过程中的中间体的质量控制,为从整体上控制评价复方石韦片的质量提供依据。
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[Abstract]
Objective To establish an HPLC fingerprint determination method of Compound Shiwei Tablets (CST), and apply it to the quality control during its preparation. Methods Agilent 5 TC C18 (2) (250 mm×4.6 mm, 5 μm) column was used for HPLC with a gradient elution of acetonitrile-0.2% phosphoric acid in mobile phase at a flow rate of 1.0 mL/min. The wavelength was 235 nm, the column temperature was 25℃, and the injection volume was 10 μL. A total of 14 batches of CST and three batches of CST intermediates (extracts and granules) were measured. Results A common pattern of HPLC fingerprints of CST was established, and 18 common peaks were demarcated and five of them were identified. The relative peak retention time RSD of each batch was < 0.3%, and the similarity between batches was > 0.990. The similarity between the same batch of CST intermediate and its preparation was > 0.990, and the correlation was good. Conclusion The established HPLC fingerprint of CST is simple, effective, and reproducible, and can be applied to the quality control of intermediates in the preparation process of the preparations, which provides a basis for the overall quality control of CST.
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