Abstract

Background: Panchkola Churna (PC) is a classical Ayurvedic formulation comprising Pippali, Pippalimool, Chavya, Chitraka, and Shunthi, used in the management of gastrointestinal disorders. Despite its therapeutic relevance, PC lacks analytical standardization and validated stability data.
Objectives: This study aimed to standardize PC by preparing three batches with authenticated raw materials from three different regions. The formulations were evaluated for pharmacognostical identity, physicochemical, microbial, and safety parameters, as well as marker-based high-performance thin-layer chromatography (HPTLC). Stability was evaluated according to the International Conference on Harmonization (ICH) guidelines.
Methods: Raw ingredients were authenticated and analyzed for their organoleptic, physicochemical, and microbiological properties in accordance with the Ayurvedic Pharmacopoeia of India (API). Finished formulations were subjected to quality control tests, powder flow analysis, HPTLC fingerprinting, and measurement of marker compounds such as piperine, piperlongumine, and 6-gingerol. An accelerated stability study was conducted to determine the shelf life.
Results: The QC parameters for the three PC batches included a total ash content of 6.03% w/w, an alcohol extractive value of 50.06% w/w, a water extractive value of 92.1% w/w, and a loss on drying of 6.96% w/w. Additionally, the acid-insoluble ash was 1.1% w/w, and the pH was 5.68. HPTLC analysis showed consistent Rf values for key markers across all batches. Quantitative tests identified piperine (387.85 µg/100 mg), piperlongumine (142.8 µg/100 mg), and 6-gingerol (25.3 µg/100 mg). Microbial contamination and heavy metal levels were within acceptable limits. The powder's flow properties demonstrated good compressibility and handling. Stability tests indicated a shelf-life of more than two years.
Conclusion: The study successfully established quality control parameters and validated the stability of PC. Marker-based HPTLC profiling, in conjunction with compliance to API and ICH standards, ensures its reproducibility, safety, and global acceptability.

Key words: Ayurveda, HPTLC, Panchkola Churna, Pharmaceutical Standardization, Quality control parameters, Shelf-life