Development of Standard Operating Procedures (SOPs), Standardization, TLC and HPTLC Fingerprinting of a Polyherbal Unani Formulation
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Background: Unani System of Medicine (USM) has its origin to Greece. To ensure and develop the quality, authenticity of Unani drugs, standardization on modern analytical parameter is essential requirement for drugs. Objectives: The aimed of the present study was to develop a standard profile of "Qurṣ-e-Mafasil" by systematic study through authenticated ingredients, pharmacognostic identification followed by physicochemical, TLC, HPTLC fingerprinting analysis as per standard protocol. Material and Methods: In this study three batches of "Qurṣ-e-Mafasil" QM were prepared by standard method as per UPI had been followed by organoleptic properties of formulation such as appearance, color, odor, taste. Powder Microscopy and physicochemical studies were carried out such as Uniformity of weight, Friability, Disintegration time, hardness, LOD, ash vales and extractive values in like aqueous, alcohol & hexane. Further qualitative tests such as Thin-Layer Chromatography (TLC), and High-Performance Thin Layer Chromatography (HPTLC) studies were also carried out to develop fingerprint pattern of the alcoholic solvent extract of QM. Phytochemical screening was carried out in different solvent extracts such as alcoholic, aqueous and chloroform extracts to detect the presence phytoconstituents in the formulation QM. Heavy metals, Microbial Load Contamination and pesticidal residues were also determined. Results: Qurṣ-e-Mafasil showed tablet-like appearance, light brown colour, mild pungent odour and acrid taste. Uniformity of weight (mg), friability (rpm), and hardness (kg/cm) and disintegration time was ranged between (500 to 503), (0.0340 to 0.038), (8.40 to 8.67) and (4-5 minutes) respectively for the three batches. Loss in weight on drying at 105˚C was ranged between (8.3425 to 8.7346). Extracted values were calculated in distilled water ranged between (30.9091 to 31.4358), hexane (1.1419 to 1.4281), and alcohol (3.3352 to 3.3962). The ash values recorded were ranged between (3.7336 to 3.8378), and acid insoluble ash (0.5859 to 0.6112).
Abstract
Background: Unani System of Medicine (USM) has its origin to Greece. To ensure and develop the quality, authenticity of Unani drugs, standardization on modern analytical parameter is essential requirement for drugs. Objectives: The aimed of the present study was to develop a standard profile of "Qurṣ-e-Mafasil" by systematic study through authenticated ingredients, pharmacognostic identification followed by physicochemical, TLC, HPTLC fingerprinting analysis as per standard protocol. Material and Methods: In this study three batches of "Qurṣ-e-Mafasil" QM were prepared by standard method as per UPI had been followed by organoleptic properties of formulation such as appearance, color, odor, taste. Powder Microscopy and physicochemical studies were carried out such as Uniformity of weight, Friability, Disintegration time, hardness, LOD, ash vales and extractive values in like aqueous, alcohol & hexane. Further qualitative tests such as Thin-Layer Chromatography (TLC), and High-Performance Thin Layer Chromatography (HPTLC) studies were also carried out to develop fingerprint pattern of the alcoholic solvent extract of QM. Phytochemical screening was carried out in different solvent extracts such as alcoholic, aqueous and chloroform extracts to detect the presence phytoconstituents in the formulation QM. Heavy metals, Microbial Load Contamination and pesticidal residues were also determined. Results: Qurṣ-e-Mafasil showed tablet-like appearance, light brown colour, mild pungent odour and acrid taste. Uniformity of weight (mg), friability (rpm), and hardness (kg/cm) and disintegration time was ranged between (500 to 503), (0.0340 to 0.038), (8.40 to 8.67) and (4-5 minutes) respectively for the three batches. Loss in weight on drying at 105˚C was ranged between (8.3425 to 8.7346). Extracted values were calculated in distilled water ranged between (30.9091 to 31.4358), hexane (1.1419 to 1.4281), and alcohol (3.3352 to 3.3962). The ash values recorded were ranged between (3.7336 to 3.8378), and acid insoluble ash (0.5859 to 0.6112).
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