PHARMACOPOEIAL STANDARDIZATION AND QUALITY PROFILING OF PARANGI KASHAYAM: A TRADITIONAL SIDDHA FORMULATION

Parangi Kashayam is a traditional Siddha decoction used for Perumootu vatham (Osteoarthritis) that lacks established pharmacopoeial standards despite its clinical use. This study aimed to develop comprehensive quality control parameters following PLIM guidelines through physicochemical profiling, chromatographic fingerprinting, and safety validation. Authenticated herbs including Smilax china, Zingiber officinale, and Senna alexandriana were formulated according to Kumbamuni Vatha Nithanam 800. Various physicochemical parameters were determined, and HPTLC fingerprinting was performed using toluene: ethyl acetate: formic acid (5:2:0.1 v/v/v) as the mobile phase with detection at 254 nm, 366 nm, and post-derivatization. Safety profiling included analysis of heavy metals by ICP-MS, pesticides by GC-MS, aflatoxins by HPLC, and microbial contamination testing. Physicochemical analysis revealed moisture content of 9.09±0.24% w/w, total ash of 4.74±0.18% w/w, acid-insoluble ash of 0.10±0.02% w/w, and pH of 5.20±0.03. The water-extractive value (15.37±0.32% w/w) was significantly higher than the alcohol-extractive value (10.50±0.21% w/w). HPTLC analysis generated reproducible fingerprints with 20 distinct spots having Rf values ranging from 0.04 to 0.82. Heavy metals, pesticides, and aflatoxins remained below quantification limits. The total bacterial count was 565 CFU/g and yeast-mould count was 26 CFU/g, both complying with pharmacopoeial limits, while pathogenic organisms were absent. These established parameters provide quality control benchmarks for pharmaceutical production and pharmacological investigation of this clinically relevant formulation.