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WHO Guidelines in Practice in India: Stability Studies on Selected CNS Active Herbal Products Through Physicochemical, Chromatographic and Biological Evaluations

Author(s):

Nancy, Jasmeen Kaur, Yogita Bansal and Gulshan Bansal*   Pages 1 - 20 ( 20 )

Abstract:


Background & Objective: Accelerated stability study (40°C/75% RH, 6 months) as well as long term stability studies (30°C/65% RH, 36 months) are conducted on three batches (I-III) of two commercially available CNS active herbal products (A and B) containing Convolvulus pluricaulis with Centella asiatica or Bacopa monnieri.

Methods: Stability samples were withdrawn at periodic intervals, and evaluated for physical stability (color, clarity, viscosity and pH), chemical stability (total phenolic (TPC), scopoletin, asiatic acid and bacoside A content), and biological activities (free radical scavenging, anti-acetylcholinesterase, and antianxiety). All stability samples retained the physical characteristics compared to corresponding control samples. Control samples exhibited significant batch-to-batch variation in TPC (46.8-65.9 mgGAE/L), scopoletin (165.78-206.15 ng/mL in A and 2.61-28.78 ng/mL in B), asiatic acid (30.14-44.92 μg/mL in B), free radical scavenging activity (IC50 0.5-1.25% v/v), AChE inhibitory activity (IC50 75.0-96.3% v/v), and antianxiety activity.

Results: The chemical indicators and biological activities were significantly decreased in both accelerated and long term stability samples compared to corresponding control samples. A correlation between scopoletin and biological activities was established in products A whereas asiatic acid/C. asiatica in product B hinders the logical correlation in product B.

Conclusion: The products exhibited significant batch-to-batch variation, and did not remain stable for recommended shelf life period, which suggested that these are suspected to lose therapeutic efficacy during their shelf life. The findings have suggested that the products do not remain stable for the recommended shelf life of three years, which implicate these to lose therapeutic efficacy during their shelf life.

Keywords:

Stability, Centella asiatica, Bacopa monnieri, Convolvulus pluricaulis, Brahmi, Shankhpushpi, Shelf life.

Affiliation:

Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala – 147002, Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala – 147002, Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala – 147002, Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala – 147002



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