Accelerated Stability Testing of Sanjivani Vati: An Ayurvedic Medicine

Introduction:Sanjivani Vati (SV) is a widely known therapeutic pill described in the Ayurvedic Formulary of India. To ensure the quality, safety, and efficacy of each and every medicine at the consumer end, it becomes important to consider the product’s shelf life being consumed. In view of this, a number of research works have been published regarding the shelf life assessment of varied Ayurvedic formulations and their modified dosage forms. Here, the presented article is aimed to evaluate the shelf life of SV using accelerated stability testing. Methods:The manufacturing of SV was carried out in the Pharmaceutical laboratory of Department of Rasashastra and Bhaishajya Kalpana, All India Institute of Ayurveda, New Delhi following the classical reference. The samples underwent an accelerated stability study as per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines Q1A (R2), maintaining temperature and humidity at 40°C ± 2°C and 75% ± 5% respectively. Relevant analytical parameters were performed at an interval of 0, 1, 3, and 6 months to monitor any degradation in the product. Results:Insignificant alterations were observed in physicochemical constants and chromatographic assay at varied stages of analysis. The formulation was found free from microbial contamination as well as heavy metals. On extrapolation of the observations, the shelf life of SV is found to be 4 years and 1 month. Conclusion:The accelerated shelf life of SV is found greater than the classical standards as well as the specifications laid down in the official gazettes of the Government of India for this dosage form. Moreover, more in-depth research is required to determine the alterations in the shelf life of various formulations along with the possible rationale due to different attributes.