甘地胶囊指纹图谱分析及指标成分含量测定

Fingerprint analysis of Gandhi capsules and determination of its content

目的:建立高效液相色谱(HPLC)指纹图谱分析法对甘地胶囊供试品指标成分含量进行测定,考察不同批次的甘地胶囊药品质量。方法:将10个批次供试品用甲醇充分溶解后采用超声方法提取,离心分离处理并采用色谱柱(ODS-3,250mm×4.6mm,5μm)将化合物分离后进行梯度洗脱。采用215nm波长对供试品指标成分含量进行测定。结果:10个批次甘地胶囊不同指标成分含量水平均在不同范围内变化,其中批次5、6、9、10的供试品中各指标成分含量水平均较低。结论:采用HPLC指纹图谱分析法能够明确测定甘地胶囊各种指标成分含量,评估药品质量。

Objective ：To establish the high performance liquid chromatography（HPLC） fingerprint analysis method to determine the contents of the index components of Gandhi capsules, and to investigate the quality of Gandhi capsule in different batches. Methods：The I0 batches of samples were extracted with methanol by ultrasonic method, which were processed by centrifugal separation and the compounds were separated by chromatography column （ODS -3,250mm × 4. 6mm, 5μm）, and the compounds were separated by gradient elution. The contents of the index components of the samples were deter- mined by 215nm wavelength. Results：The content levels of different index components in 10 batches of Gandhi capsules were varied in different ranges, among which the contents of each indexes in the test sample of 5, 6, 9, 10 batches were lower. Conclusion：The HPLC fingerprint analysis method is used to determine the contents of various indexes of Gandhi capsules, and to evaluate the drug quality.