用于尤纳尼医学体系伊曲法尔制剂质量控制分析的高效薄层层析法和超高效液相色谱-串联质谱法
HPTLC and UPLC-MS/MS Methods for Quality Control Analysis of Itrifal Formulations of Unani System of Medicine.
作者信息
Rab Rehan Abdur, Zahiruddin Sultan, Ibrahim Mohammad, Husain Faisal, Parveen Rabea, Khan Washim, Ahmad Farhan J, Khan Asim A, Ahmad Sayeed
机构信息
Jamia Hamdard, School of Pharmaceutical Education and Research, Department of Pharmaceutics, Nano Medicine Laboratory, New Delhi 110062, India.
Jamia Hamdard, School of Pharmaceutical Education and Research, Department of Pharmacognosy and Photochemistry, Bioactive Natural Product Laboratory, New Delhi 110062, India.
出版信息
J AOAC Int. 2020 Jun 1;103(3):649-658. doi: 10.5740/jaoacint.19-0231.
BACKGROUND
Ultra-performance LC (UPLC)-tandem MS (MS/MS) and high-performance TLC (HPTLC) assay methods were developed for chemical fingerprinting and quantitative analysis of bioactive constituents of a certain "Itrifal formulation," a traditional kind of Unani medicine.
OBJECTIVE
In the present investigation, HPTLC and UPLC-MS/MS methods were developed and validated for the detection and quantification of major metabolites present in itrifal formulation.
METHODS
The metabolites present in the formulation were separated using modern chromatographic techniques, and a quantitative analysis was performed. Analytical performance of the proposed HPTLC and UPLC-MS/MS methods was validated as per the defined guidelines with respect to linearity, accuracy, precision, robustness, and specificity.
RESULTS
The developed UPLC-MS/MS and HPTLC methods were used for quantification of gallic acid, tannic acid, catechin, and quercetin. All four constituents were quantified by UPLC-MS/MS, while two constituents were quantified by HPTLC in the commercial itrifal formulation. The calibration plot was found to be linear, accurate, precise, robust, and specific for both HPTLC and UPLC-MS/MS.
CONCLUSIONS
The present methods were successfully applied for analysis of the given markers in itrifal formulations. The same can be used for QC and stability testing of itrifal formulations.
背景
开发了超高效液相色谱（UPLC）-串联质谱（MS/MS）和高效薄层色谱（HPTLC）分析方法，用于某种传统尤那尼药物“伊特里法尔制剂”生物活性成分的化学指纹图谱分析和定量分析。
目的
在本研究中，开发并验证了HPTLC和UPLC-MS/MS方法，用于检测和定量伊特里法尔制剂中存在的主要代谢物。
方法
使用现代色谱技术分离制剂中存在的代谢物，并进行定量分析。根据既定指南，对所提出的HPTLC和UPLC-MS/MS方法的分析性能在线性、准确性、精密度、稳健性和特异性方面进行了验证。
结果
所开发的UPLC-MS/MS和HPTLC方法用于没食子酸、鞣酸、儿茶素和槲皮素的定量分析。在市售伊特里法尔制剂中，所有四种成分均通过UPLC-MS/MS进行定量，而两种成分通过HPTLC进行定量。校准曲线对于HPTLC和UPLC-MS/MS均呈线性、准确、精密、稳健且具有特异性。
结论
本方法成功应用于伊特里法尔制剂中给定标志物的分析。同样可用于伊特里法尔制剂的质量控制和稳定性测试。
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