Quantitative evaluation and chromatographic fingerprinting for the quality assessment of Pudilan tablet

IF 1.7 4区化学 Q3 CHEMISTRY, ANALYTICAL

Acta Chromatographica Pub Date : 2022-10-28 DOI:10.1556/1326.2022.01084

Mengya Lu, Q. Tang, Chenyu Zhou, Zhizheng Fang, Zheng Fan, Xiangyu Li, R. Han, X. Tong

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引用次数: 0

Abstract

An easy, quick, and sensitive approach adopting ultra-performance liquid chromatography (UPLC) equipped with diode array detector was used to analyze and systematically evaluate the quality of Pudilan tablets manufactured by 12 distinct pharmaceutical companies. In this research, 15 peaks were chosen as the common peaks to assess the similarities for different batches (S1–S43) of Pudilan tablet samples. In comparison with the control fingerprint, similarity values for 43 batches of samples exceeded 0.922. In addition, by analyzing the reference substances of epigoitrin, caffeic acid, chlorogenic acid, acetylcorynoline, baicalin and baicanshialein, the chromatogram of the 6 reference substances was established. The recoveries for the reference substances which demonstrated good regression in the linear range (r 2 > 0.999) were in the range of 98.3–101.1%. The results demonstrated that the established method was highly accurate, efficient and reliable. This study provides a valid, dependable and pragmatic method to evaluate the quality of Pudilan tablet.

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蒲地兰片的定量评价及色谱指纹图谱质量评价

采用二极管阵列检测器的超高效液相色谱法，对12家不同制药公司生产的普地兰片进行了简单、快速、灵敏的质量分析和系统评价。在本研究中，选择了15个峰作为共有峰，以评估不同批次（S1–S43）普地兰片剂样品的相似性。与对照指纹图谱相比，43批样品的相似性值超过0.922。此外，通过对表油苷、咖啡酸、绿原酸、乙酰炔诺啉、黄芩苷和白苍耳素的对照品进行分析，建立了6种对照品的色谱图。标准品的回收率在98.3～101.1%之间，线性范围（r2＞0.999）良好，结果表明，该方法准确、高效、可靠。本研究为评价普地兰片的质量提供了一种有效、可靠、实用的方法。

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来源期刊

Acta Chromatographica 化学-分析化学

CiteScore

4.00

自引率

0.00%

发文量

审稿时长

2.3 months

期刊介绍： Acta Chromatographica Open Access Acta Chromatographica publishes peer-reviewed scientific articles on every field of chromatography, including theory of chromatography; progress in synthesis and characterization of new stationary phases; chromatography of organic, inorganic and complex compounds; enantioseparation and chromatography of chiral compounds; applications of chromatography in biology, pharmacy, medicine, and food analysis; environmental applications of chromatography; analytical and physico-chemical aspects of sample preparation for chromatography; hyphenated and combined techniques; chemometrics and its applications in separation science.