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目的建立甘地胶囊HPLC指纹图谱分析方法及测定指标成分含量,并以此考察甘地胶囊的质量。方法样品经甲醇溶解后,超声提取、离心,用Inertsil~(?)ODS-3色谱柱(250 mm×4.6 mm,5μm)分离化合物,流动相为乙腈与0.5‰磷酸(pH=2.25),梯度洗脱,流量为1 mL·min~(-1),柱温为室温,215 nm波长测定,外标法定量;记录甘地胶囊的HPLC-UV指纹图谱。结果甘地胶囊指纹图谱用加样回收法与对照品比较,检出8个鉴定峰:咖啡酸、芦丁、阿魏酸、黄芪甲苷、野黄芩素、黄芩苷、黄芩素、汉黄芩素;样品中多数峰可以达到良好分离;8个测定化合物在各自的浓度范围内均有良好的线性(r>0.999),方法回收率分别为咖啡酸(95.33±5.03)%、芦丁(99.33±1.15)%、阿魏酸(99.33±1.15)%、黄芪甲苷(97.20±4.23)%、野黄琴素(96.67±6.11)%、黄芩苷(99.67±1.53)%、黄芩素(101.33±3.21)%、汉黄芩素(98.00±2.65)%。结论多批次甘地胶囊中甘地胶囊指纹图谱特征明确,相似度>0.9,指标成分含量可控制在一定的范围,说明药品质量稳定,HPLC-UV指纹图谱可以为甘地胶囊提供有效的质量控制方法。
OBJECTIVE To establish a method for HPLC fingerprint analysis of Gandhi capsules and to determine the content of index components, and to investigate the quality of Gandhi capsules. Methods The samples were dissolved in methanol, extracted by ultrasound and centrifuged. The compounds were separated on an Inertsil ODS-3 column (250 mm × 4.6 mm, 5 μm) using acetonitrile and 0.5 ‰ phosphoric acid (pH = 2.25) The mobile phase was eluted at a flow rate of 1 mL · min ~ (-1). The column temperature was at room temperature and determined at 215 nm. The HPLC-UV fingerprints of Gandhi capsules were recorded. Results Fingerprints of Gandhi Capsules were compared with the reference substance by the method of sample recovery. Eight peaks were identified: caffeic acid, rutin, ferulic acid, astragaloside, baicalein, baicalin, baicalein and wogonin. The majority of peaks in the sample can be well separated. The eight compounds have good linearity (r> 0.999) in their respective concentration ranges. The recovery rates of caffeic acid (95.33 ± 5.03)%, rutin (99.33 ± 1.15 (99.33 ± 1.15)%, Astragaloside (97.20 ± 4.23)%, picolysin (96.67 ± 6.11)%, baicalin (99.67 ± 1.53)% and baicalein (101.33 ± 3.21)%, respectively. Wogonin (98.00 ± 2.65)%. Conclusions The fingerprint of Gandhi Capsules in multiple batches of Gandhi Capsule has definite characteristics, similarity> 0.9, and the content of indicator components can be controlled within a certain range, indicating that the quality of the drugs is stable and HPLC-UV fingerprint can provide effective quality control method for Gandhi Capsules.