To perform the accelerated stability studies
Materials Required:
● Salicylic acid
● 0.1 N HCl
● Ferric nitrate solution
● Distilled water
● Spectrophotometer
● Cuvettes, test tubes, beakers, conical flasks
● Pipettes and measuring cylinders
● Digital weighing balance
● Water baths maintained at 40°C, 60°C, and 70°C
Procedure:
- Prepare a standard solution by dissolving 100 mg of salicylic acid in 100 mL distilled water to obtain a 1 mg/mL standard solution.
- Prepare an acid solution by adding 8.5 mL concentrated HCl to distilled water and make up to 100 mL (handle with care).
- For the calibration curve, pipette known concentrations of salicylic acid into test tubes, add ferric nitrate reagent, mix well, and measure absorbance at 540–547 nm.
- Plot absorbance versus concentration to obtain the calibration curve.
- Prepare an aspirin solution of known concentration and incubate in water baths at 40°C, 60°C, and 70°C for 10, 20, and 30 minutes.
- Withdraw aliquots at each time interval, cool them, add ferric nitrate reagent, and measure absorbance.
- Calculate the percentage of undecomposed drug and plot log(% drug undecomposed) vs. time to confirm first-order kinetics.
- From the slope, determine rate constant (k) at each temperature.
- Plot log k vs. 1/T (Arrhenius plot) to determine activation energy (Ea).
- Estimate shelf life (t₉₀) using the first-order equation.