Shelf-life evaluation of Indukanta Ghritam: A preliminary study

Abstract

Background: The concept of Saviryata Avadhi (shelf life) of different Ayurveda dosage forms is well described in Sharngadhara saṃhita. Shelf life is an important component and is mandatory to be displayed on the label of all medicinal products. This is also applicable to Ayurveda; thus, it becomes essential to establish shelf life of formulations that are being marketed and used in therapeutics. An attempt has been made in this study to evaluate shelf life of Indukanta Ghritam (IKG) which is not reported till date though in general it has been quoted by Gazette of India, that is, 2 years. Aim: To evaluate the shelf life of IKG through the accelerated stability study. Materials and Methods: Five batches were prepared according to Ayurveda Pharmacopoeia of India and the observations and results were systematically recorded. Physicochemical parameters were measured at the temperature of 40°C ± 2°C and the relative humidity was 75% ± 5%. The analysis was carried out at the intervals of 0, 1, 3, and 6 months, and the average 10% degradation time was calculated and extrapolated to find the shelf life as per ICH guidelines and high-performance thin-layer chromatography (HPTLC) analysis of sample was also carried out. Results: The average percentage loss in final product was 7.71% in IKG. The shelf life of IKG is found to be 19 months. Conclusion: The classics have mentioned the shelf life as 16 months, whereas the Gazette of India states the shelf life as 2 years for Ghrita. The shelf life of IKG is equal to the classic. This might be because of the precautions observed during the manufacturing and storing phases of the drug.