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.

中文翻译：

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HPTLC和UPLC-MS / MS方法，用于Unani系统药物离心制剂的质量控制分析。

背景：开发了超高效液相色谱（UPLC）-串联质谱（MS / MS）和高性能TLC（HPTLC）测定方法，用于化学指纹图谱和定量分析某些“离心配方”（一种传统的配方）的生物活性成分。乌纳尼药。目的：在本研究中，开发并验证了HPTLC和UPLC-MS / MS方法用于检测和量化离心制剂中主要代谢物。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。根据定义的线性，准确性，精密度，鲁棒性和特异性指南，验证了所提出的HPTLC和UPLC-MS / MS方法的分析性能。结果：所开发的UPLC-MS / MS和HPTLC方法用于定量没食子酸，单宁酸，儿茶素和槲皮素。通过UPLC-MS / MS对所有四种成分进行定量，而在商用离心制剂中，通过HPTLC对两种成分进行定量。发现校准图是线性的，准确的，精确的，鲁棒的，并且对于HPTLC和UPLC-MS / MS都是特定的。结论：本方法已成功用于离心制剂中给定标志物的分析。同样可以用于离心制剂的质量控制和稳定性测试。