Shelf Life Assessment of Picralima nitida and Glibenclamide Using Bio-Based Dose-Response Relationship Method

Abstract

Stability testing confirms the safety and quality of an active pharmaceutical ingredient or product. The shelf life of Picralima nitida (herbal drug) and glibenclamide were evaluated using the bio-based dose-response relationship method by the use of animal model based on their pharmacological activity. Glibenclamide was used as the comparative drug for the assessment of the specifications for Picralima nitida. Their shelf life was estimated by means of accelerated stability testing on the basis of the first-order kinetics of degradation and the time required to degrade 10% of a drug at 27°C (t10%). The influence of storage time (1, 2, 3 and 4 weeks) and temperature (45, 60, and 70 °C) on the stability of the drug samples were studied. Their half-life (t1/2) and the toxicity level (LD50) were also estimated. The concentrations of the drugs were found to decline with an increase in storage time and temperature. The shelf life of glibenclamide and Picralima nitida were found to be 10.54 and 3.15 weeks, respectively; the half-life of glibenclamide and Picralima nitida were found to be 70 and 20.94 weeks, respectively. Their pharmacological activity varied due to the pharmacokinetic profile of the animal models. Also, Picralima nitida extract was found to be practically nontoxic on the tested animals (LD50 = 14.97 g/kg). From the study, it was observed that glibenclamide (used as a comparative drug) aided in the estimation of the capacity of Picralima nitida to retain its specification (quality and safety) for treatment under the influence of environmental conditions.