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我们建立了戊己胃漂浮缓释片指纹图谱的定性定量研究,以便更好地控制制剂质量。采用高效液相色谱法,Agilent ZORBAX SB-C18柱(250 mm×4.6 mm,5μm)为色谱柱,以乙腈–0.05 mol/L磷酸二氢钾溶液为流动相进行梯度洗脱,流速1.0 m L/min,检测波长225 nm,柱温30 ℃,进样量10μL,检测时间为75 min,采用指纹图谱相似度软件(2004A版)进行数据分析。通过方法学考察建立了戊己胃漂浮缓释片指纹图谱的定性定量检测方法,并对11批戊己胃漂浮缓释片进行指纹图谱检测分析,共检测出17个共有峰,11批制剂相似度均大于0.9,制剂生产工艺稳定可行。该方法具有可操作性,能有效控制戊己胃漂浮缓释片的质量。
We have established a qualitative and quantitative fingerprint of pentosidine floating tablets in order to better control the quality of the preparation. High performance liquid chromatography (HPLC) was performed on an Agilent ZORBAX SB-C18 column (250 mm × 4.6 mm, 5 μm) using a mobile phase of acetonitrile-0.05 mol / L potassium dihydrogen phosphate as mobile phase at a flow rate of 1.0 mL / min, the detection wavelength was 225 nm, the column temperature was 30 ℃, the injection volume was 10μL and the detection time was 75 min. Data were analyzed by fingerprint similarity software (2004A version). The method of qualitative and quantitative determination of fingerprints of pentosidine floating tablets was established by methodological study. Fingerprinting analysis of 11 batches of pentosidine floating tablets was carried out. A total of 17 common peaks were detected and 11 batches were similar Degrees are greater than 0.9, the preparation of the production process is stable and feasible. The method has the operability, can effectively control the quality of pentosadil floating sustained-release tablets.