Shelf-life evaluation of Kasisadya Ghritam prepared by two different methods

Abstract

BACKGROUND: Kasisadya ghritam (KG) is a herbomineral formulation comprising 32 natural ingredients mentioned in Sharangadhara samhita. Different methods of preparation have been mentioned regarding the same especially in respect to the heating pattern, that is, Agnipaki and Suryatapi. As this medicine has shown promising results in various ailments since the ages, the use of this medicine has become very prevalent in recent clinical practices. The globalization and commercialization of Ayurveda sought for the stability of this medicine is unfortunately not evaluated to date. Therefore, a plan had been made to evaluate the shelf life of this formulation by following parameters prevalent in the respective scenario. The aim of this study was to evaluate the shelf life of both the samples of Kasisadya ghritam Suryatapi (KGS) and Kasisadya ghritam Agnipaki (KGA) through basic analytical parameters and chromatographic fingerprinting. MATERIALS AND METHODS: Stability period of both the samples was determined by the accelerated stability study as per International Council of Harmonization (ICH) Guidelines Q1A (R2). The test drugs were stored at 40°C ± 2°C temperature and 75 ± 5% relative humidity and withdrawn at the intervals of 0, 1st, 3rd, and 6th months of storage. Physicochemical parameters of KGS and KGA were analyzed at the intervals of 0, 1, 3, and 6 months, whereas chromatographic fingerprinting was done initially and after 6 months of the study. Based upon the observations, intercept, slope, 10% degradation of the sample, and the shelf life of both the samples were calculated. RESULTS: Basic analytical parameters showed both the samples deteriorate by time. By calculating the analytical data, 10% degradation of KGS was found in specific gravity (0.83), viscosity (194.4), acid value (6.58), peroxide value (1.97), and total fatty matter (78.83). The data of KGA revealed 10% degradation in parameters, that is, specific gravity (0.8295), viscosity (496.8), acid value (0.864), peroxide value (1.341), and total fatty matter (82.81). Rf values obtained from high-performance thin-layer chromatography (HPTLC) of both samples initially and after 6 months showed minimum deterioration of the product. Microbial count and heavy metals were below the permissible limits in both the samples. Accelerated stability study reveals the shelf life of KGS as 3.8 years, whereas that of KGA as 4.4 years. CONCLUSION: Rule 161 B of Drugs and Cosmetics Rule, 1945 mentioned the shelf life of medicated Ghrita as 2 years. This time period is general, and different formulations may have different shelf lives based upon several factors. The samples tested in the current study, that is, KGS and KGA, are found to have a shelf life of 3.8 and 4.4 years, respectively, which are more than the time specified in the guidelines. The findings suggest that the sample prepared by subjecting to heat has more shelf life than the sample prepared by subjecting to sunlight.