Pharmaceutical Standardization and Stability Analysis of Pippalyadi Yonivarti and its Ayurvedic Vaginal Suppository

Abstract Background: Yonivarti (Ayurvedic vaginal suppository) possesses healing, anti-inflammatory, and antibacterial properties. Despite its therapeutic relevance, Pippalyadi Yonivarti (PV) and its suppository lack standardization and stability data. Materials and Method: PV was prepared in three batches (2 kg each), and Pippalyadi vaginal suppositories (PS) in batches of 200 units using the fusion method with a water-soluble base. Efforts have been made to develop standard operating procedures (SOPs), and quality control (QC) as per the Ayurvedic Pharmacopeia of India, and stability studies were evaluated as per International Conference on Harmonization (ICH) guidelines. Observations and Results: PV showed loss on drying: 8.19% ±0.96% (w/w), pH: 5.85 ± 0.06, water extractive value: 86.78% ±0.87% (w/w), alcohol extractive value: 31.36% ±0.63% (w/w), total ash value: 20.76% ±0.47% (w/w), acid insoluble ash: 0.21% ±0.015% (w/w), average weight: 2.91 ± 0.04, hardness: 2.12 ± 0.05 kg/cm 2 , friability: 0.17% ±0.04% (w/w), and disintegration time (DT): 54 ± 13.6 min. The QC parameters for PS, including weight, melting range, pH, liquefaction, and DT, were within acceptable limits. High-performance thin-layer chromatography (HPTLC) quantification of PV showed 960 mg/100 mg of piperine and 524 mg/100 mg of dehydrocostus lactone, compared to PS. Observed differences were attributed to PS due to the poor aqueous solubility of ingredients. Stability tests indicated a shelf-life of 29 months for PV and 12 months for PS. Conclusion: SOPs, QC parameters, and HPTLC quantification confirm the reproducibility, safety, and stability of both formulations, reinforcing their suitability for incorporation into modern gynecological therapies.