Process Validation of Pippali Rasayana prepared by one and seven Bhavana of Palasha Ksharodaka: A Comparative Study

Background: Ayurvedic pharmaceutics emphasizes systematic preparation and standardization of formulations to ensure consistency, quality, safety, and efficacy. This study aimed to develop a Standard Manufacturing Procedure (SMP) for Palasha Kshara, Palasha Ksharodaka, and Pippali Rasayana prepared using one and seven Bhavana of Palasha Ksharodaka. Materials and Methods: Authenticated fresh Palasha (Butea monosperma (Lam.) Kuntze) Panchanga and dried Pippali (Piper longum Linn.) fruits were used. Palasha Panchanga was dried and subjected to Bhasmikarana to obtain ash, followed by repeated extraction, sedimentation, decantation, and filtration to prepare Ksharajala. Evaporation yielded Palasha Kshara. Pilot studies optimized critical parameters for Palasha Ksharodaka preparation and Bhavana. Pippali fruits underwent one and seven Bhavana, followed by Bharjana in Goghrita and powdering through sieve no. 120#. Three batches of each major process were prepared to establish the SMP. Results: From 1520 kg fresh Palasha Panchanga, 94 kg ash was obtained (6.91% yield based on dried material). Palasha Kshara showed an average yield of 254 g (8.44%) from 3 kg ash. One-fourth evaporation produced Palasha Ksharodaka with an average yield of 898.33 mL (74.86%). One and seven Bhavana resulted in average weight gains of 121.67 g (19.57%) and 291.67 g (58.23%), respectively. Final powder yields were 590.33 g (92.38%) for PR-1 and 752.33 g (93.46%) for PR-7. Conclusion: The study established reproducible pharmaceutical parameters and an SMP for all three formulations, demonstrating progressive changes in weight and processing characteristics with increasing Bhavana cycles.