Pharmacognostical, Pharmaceutical and Analytical Standardization of Shirishadi Arka through Physicochemical Evaluation, HPTLC Profiling, GC MS Characterization and Safety Assessment.

Abstract

Background: Standardization of Ayurvedic formulations is essential to ensure their safety, quality, and reproducibility. Shirishadi Arka is an Anubhuta Yoga traditionally indicated in respiratory disorders such as Shwasa and Kasa. Aim: To prepare Shirishadi Arka and establish its pharmacognostical, pharmaceutical, and analytical standardization using modern scientific parameters. Objectives: To understand the preparation of Shirishadi Arka by method of distillation. To determine the analytical tests like physico-chemical parameters, and tests for heavy metals to assure to evaluate the pharmaceutical and analytical standardization. Gas chromatography-mass spectrometry analysis to investigate potential properties of Shirishadi Arka. Material and Methods: The formulation was prepared by classical distillation (Arka Kalpana) using Shirisha (Albizia lebbeck), Musta (Cyperus rotundus), and Kantakari (Solanum xanthocarpum). Pharmacognostical evaluation was carried out for authentication of raw drugs. Physicochemical parameters, microbial load, heavy metal analysis, pesticide residue were performed as per API guidelines. High Profile Thin Layer Chromatography (HPTLC) was employed for preliminary fingerprinting, while Gas Chromatography–Mass Spectrometry (GC–MS) analysis was conducted for phytochemical profiling. All experiments were performed in triplicate (n = 3), and results were expressed as mean ± standard deviation. Analytical methods were validated for precision and repeatability. Results: The formulation complied with API standards. Physicochemical parameters showed pH 7.00 ± 0.05, specific gravity 1.0033 ± 0.002, and total solid content 0.052 ± 0.003 % w/v. Microbial, heavy metal and pesticide residue analysis were within permissible limits. HPTLC analysis demonstrated distinct chromatographic patterns. GC–MS analysis identified 50 phytoconstituents, including fatty acids, terpenoids, and phytosterols such as n-hexadecanoic acid, γ-tocopherol, and β-sitosterol derivatives. %RSD values were within acceptable limits, indicating good reproducibility. Conclusion: The study establishes a comprehensive standardization profile of Shirishadi Arka. The presence of bioactive compounds with known anti-inflammatory and antioxidant properties supports its traditional use in respiratory disorders such as COPD (Tamaka Shwasa).