Background: Standardization of Unani formulations is essential to assess the quality and safety of drugs to establish their acceptance internationally as well as in nationally. Safoof-e-Pathar phori is a polyherbomineral formulation that contains six different plant and mineral constituents: Didymocarpus pedicellata, Dolichos biflorus, Rheum emodi, Raphanus sativus, potassium carbonate, and potassium nitrate.
Objective: The objective of the study is to develop and establish the quality of Safoof-e-Pathar phori, used for antilithiatic activity using chromatographic analysis.
Methods: This study involves comparative fingerprint profiling of an Unani polyherbomineral formulation with its plant constituents by high-performance TLC (HPTLC), HPLC, and GC-MS. The authenticity of the Unani polyherbomineral formulation using comparative HPLC and GC-MS fingerprint profiling was achieved by comparing the retention time of peaks matching with plant drugs.
Results: In HPTLC, comparative fingerprinting was done on the basis of retardation factor values of compounds separated on HPTLC plates of the formulation and the single drugs. The relative retention times of the characteristic peaks in the HPLC fingerprinting were established for identification of the Unani poly-herbo-mineral formulation, whereas GC-MS was used for comparative fingerprint profiling of different compounds present in single drugs and in formulation through the National Institute of Standards and Technology and Wiley libraries using mass by charge ration (m/z) of detected compounds.
Conclusions: The fingerprint analysis approach is the most potent tool for quality control of polyherbal medicines because of its accuracy and reliability, and it also helps in identification and authentication and prevents adulteration.
Highlights: The developed chromatographic methods enable the quality and safety profile of the products.
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