Quality control and shelf-life study of Ayush CCT formulation

BACKGROUND: One of the most widely popular brews globally is green tea/black tea, prepared by steeping the leaves of Camellia sinensis (L.) Kuntze plant. The examination of shelf-life proves to be a crucial tool in Ayurvedic formulations, particularly for ensuring the prolonged durability of the finished products. METHODS: The formulation underwent shelf-life studies maintaining conditions at 30°C ± 2°C and 65% RH ± 5% RH. The shelf-life dynamics were scrutinized through withdrawals at 0 day and at 3-month intervals to maintain the efficacy over a period of 24 months. In the current research, notable alterations were not detected in diverse physical, chemical, and safety parameters studied for shelf-life assessment. These parameters include pH, loss on drying at 105°C, ash values, extractive values, microbial contamination, high-performance thin-layer chromatography (HPTLC) profile, thermal analysis, and aflatoxins, all evaluated at different intervals throughout the entire study period. RESULTS: The current research study comprises of HPTLC fingerprint profiling of C. sinensis leaf and formulation, employing the solvent system of toluene: ethyl acetate: formic acid (6.5:3.4:0.1) with caffeine as the reference standard and safety parameters along with total phenolic content (6.9379 %w/w) and total flavonoid content (3.31 %w/w). The quantitative estimation values of caffeine in Ayush CCT and in C. sinensis leaf were 0.83% and 2.44%, respectively. CONCLUSION: It can be inferred that the Ayush CCT formulation demonstrates a shelf-life of more than 2 years. The study encompassed the assessment of shelf-life, as well as the qualitative and quantitative estimation of caffeine as a bioactive constituent in Ayush CCT formulation and C. sinensis extract.