Photostability evaluation of Jawarishe Jalinoos

Abstract

Jawarishe Jalinoos (JJ) is an orally used formulation available in semisolid dosage form, prepared with powdered plant materials mixed in honey or sugar syrup. It has many admirable pharmacological effects and used in Unani medicine to treat various acute and chronic disorders since ancient times. The ICH Harmonised Tripartite Guideline stated that photostability testing should be an essential part of stability testing to confirm that light exposure does not result in an unacceptable change in drugs substance and finished products. To date, the effect of light on JJ is not studied, in this study photostability evaluation of JJ was carried out. The test sample was manufactured with genuine ingredients in the in-door pharmacy of the National Institute of Unani Medicine. JJ was packed in two transparent polyethylene terephthalate airtight containers. The first sample was analysed at zero-day and the second sample was placed in a stability chamber subjected to light challenge with an overall illumination of 1.2 million lux hours combined with near ultraviolet energy of 200-watt hours per square meter by using option 2, along with 30±2°C temperature and relative humidity 70±5%. Analysis of both finished products showed no considerable changes in organoleptic characters. Less than 5% variation was observed in physicochemical parameters. HPTLC fingerprinting showed justifiable variation. Microbial load and specific counts were within the limit prescribed by WHO. As no unacceptable changes were noted in JJ subjecting to light challenge, it is concluded that JJ is a photostable Unani compound formulation.