SCIENTIFIC EVIDENCE FOR STABILITY EVALUATION AND SHELF-LIFE ESTIMATION OF VACHA CHURNA BY USING RP-HPLC

• Published in: International journal of applied pharmaceutics pp. 154 - 162
• Main Authors: NIHARIKA, G., MD ISHA ALI, SYEDA ALISHA, BHAT, KRISHNAMURTHY, HADAPAD, BASAVARAJ S., MUDDUKRISHNA, B. S., RAVI, GUNDAWAR, BALLAL, MURALIDHAR, VASANTHARAJU, S. G.
• Format: Journal Article
• Language: English
• Published: 07.07.2024
• ISSN: 0975-7058; 0975-7058
• DOI: 10.22159/ijap.2024v16i4.51117

Objective: The concept of shelf life of classical Ayurvedic formulations is clearly defined in the classical literature of Ayurveda. Considering the Ayurveda development and recent gazette notification of 161-B, it is important to evaluate the stability of the Ayurvedic products based on scientific evidence. The study aims to evaluate the stability and estimate the shelf life of Vacha churna by using the marker Beta-asarone. The chemical marker of the Vacha churna has been identified as Beta-asarone. Methods: A stability-indicating RP-HPLC method has been developed and validated for Beta-asarone. The method utilises a Stationary phase C18 column and a mobile phase composed of acetonitrile and ammonium acetate buffer. Beta-asarone underwent various stress conditions like acid and base hydrolysis, oxidation, temperature and photolytic degradation. The Vacha churna has been stored in a stability chamber for both accelerated and long-term testing. The formulation was taken at specific time intervals and the marker content was analysed using RP-HPLC. Results: Beta-asarone was eluted at 6.03 min. The linear regression equation was found to be y = 28211x-1349.3 with a R2 of 0.9991. Stress studies confirmed the absence of co-eluting peaks and degradants under various stress conditions. Based on the analysis of Beta-asarone marker content, the shelf life of Vacha churna was estimated to be 62.40 mo. Conclusion: Data from RP-HPLC method and stability studies can be employed for routine commercial stability assessments. Due to the absence of a Pharmacopoeial RP-HPLC method, local Ayurvedic manufacturers can utilise the developed method. The investigated shelf life thus serves as a medium of chemical stability based on the scientific evidence.