Abstract
Forced Degradation Studies of Mangiferin and Gallic Acid by High Performance Thin Layer Chromatography
Department of Quality Assurance, Bharati Vidyapeeth’s College of Pharmacy, Navi Mumbai, Maharashtra 400614, India
Correspondence Address:
Aruna P. Jadhav, Department of Quality Assurance, Bharati Vidyapeeth’s College of Pharmacy, Navi Mumbai, Maharashtra 400614, India, E-mail: aruna.jadhav@bvcop.in
Stress degradation of mangiferin and gallic acid was induced to establish the stability indicating power of the validated high performance thin layer chromatography method. Mangiferin is a C-glycosyl xanthone derivative with many health-endorsing biological activities such as hypoglycaemic, antioxidant, and anti-inflammatory. Similarly, gallic acid a phenolic compound possesses antioxidant, antimicrobial, anti-inflammatory, anticancer, cardioprotective, gastroprotective, and neuroprotective effects. To elucidate the intrinsic stability, both molecules were subjected to a forced degradation process under conditions more severe than accelerated ones, generating degradation products for further study. Forced degradation studies were performed according to stability guidelines by International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use Q1(R2) and Q1B. Accordingly, mangiferin and gallic acid were exposed to oxidation, acid hydrolysis, alkaline hydrolysis, photolysis, as well as hydrolytic and thermal degradation experiments. Forced degradation results show that mangiferin was less susceptible to acidic and hydrolytic conditions and moderately susceptible to dry heat and photostability conditions. Mangiferin was highly susceptible to alkali and oxidative conditions. Gallic acid was less susceptible to photostability conditions and moderately susceptible to alkali, hydrolytic, and dry heat conditions. Gallic acid was highly susceptible to acid and oxidative conditions.
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