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目的:建立产康乐颗粒HPLC指纹图谱及4种成分含量测定方法,为质量控制提供依据。方法:Hypersil ODS2色谱柱(4.6 mm×250 mm,5μm),以0.1%磷酸水溶液和乙腈为流动相,梯度洗脱,检测波长为280 nm。结果:建立了产康乐颗粒的指纹图谱,确立了20个共有峰,10批成品指纹图谱相似度在0.95以上;同时对其4个有效成分进行了含量测定。结论:建立的HPLC指纹图谱及含量测定方法符合相关要求,适合产康乐颗粒的质量控制。
OBJECTIVE: To establish a HPLC fingerprinting and the determination methods of four components of Kanglule granules, which can provide the basis for quality control. METHODS: The Hypersil ODS2 column (4.6 mm × 250 mm, 5 μm) was eluted with a gradient of 0.1% phosphoric acid and acetonitrile. The detection wavelength was 280 nm. Results: The fingerprints of producing Kangle Granules were established and 20 common peaks were established. The fingerprint similarity of 10 batches of finished products was above 0.95. At the same time, the content of 4 active ingredients was determined. Conclusion: The establishment of HPLC fingerprint and determination of content meet the relevant requirements, suitable for the quality control of Kangle particles.