Quality Control and GC-MS Study of an Ayurvedic Linctus Formulation - Kalyanaka Guda

Background: Kalyanaka Guda (KG) is a polyherbal linctus preparation of Ayurveda widely used in the management of anemia, hemorrhoids, skin diseases etc., For such commonly practiced formulations, there exists lack of preliminary quality control (QC) data. Hence this study aimed to test KG’s basic QC parameters and subjected it to analysis with Gas Chromatography Mass Spectrometry (GC-MS). Methodology: Following the classical method of preparation of KG, analyses such as organoleptic characters, loss on drying, total ash, acid insoluble ash, total fat content qualitative inorganic elemental analysis were performed. A method for Thin Layer Chromatography (TLC) was also developed using n-hexane, chloroform and methanolic extracts of KG using different trials. All the three extracts were then subjected to analysis in GC-MS. Results: Results revealed characteristic colour, odour and appearance of KG. Whereas pH, loss on drying, total ash, acid insoluble ash and total fat content were found as 3.74, 9.34%, 3.09%, 0.46% and 4.2% respectively. Elements such as sodium, sulphate and chloride were found in KG. Only TLC of methanolic extract with mobile phase Toluene:Ethyl acetate:Formic acid:Methanol (3:3:0.8:0.2) exhibited good chromatographic separations among the others. GC-MS of methanolic extract identified 13 compounds. Conclusion: The study successfully rendered basic QC parameter findings and also developed methodology for TLC for important and commonly used formulations like Kalyana Guda. The findings of GC-MS helped identify compounds that had formed as a secondary metabolite during the pharmaceutical processing of Kalyanaka Guda.