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Formulation development and stabililty testing of extemporaneous suspension prepared from dapsone tablets
Nitin Kaila1, Mohamed El-Ries, A Riga
1Industrial Pharmacy Division, College of Pharmacy, Pharmacy Practice Department, The University of Toledo, Toledo, Ohio.
International Journal of Pharmaceutical Compounding
|August 28, 2013
Summary
A stability-indicating method was developed for dapsone suspensions. The study determined dapsone
Area of Science:
- Pharmaceutical Sciences
- Analytical Chemistry
Background:
- Dapsone is a crucial medication, but its stability in various formulations requires thorough investigation.
- Extemporaneous suspensions are often used for pediatric or geriatric patients, necessitating stability data.
Purpose of the Study:
- To develop and validate a stability-indicating analytical method for dapsone in suspension.
- To assess the chemical stability and determine the shelf-life of an extemporaneously formulated dapsone suspension.
Main Methods:
- Reverse-phase high-performance liquid chromatography (RP-HPLC) was employed for method development and validation.
- Accelerated stability testing was conducted at elevated temperatures (4-70 °C) over 91 days.
- Thermodynamic parameters like enthalpy and entropy of solution were calculated.
Main Results:
- The RP-HPLC method proved stability-indicating for dapsone quantification.
- The calculated water solubility of dapsone is 0.208 mg/mL at 25 °C.
- The shelf-life was determined to be 31.67 days at 25 °C and 230.76 days under refrigeration (4 °C).
Conclusions:
- A validated stability-indicating RP-HPLC method is suitable for dapsone suspension analysis.
- The formulated dapsone suspension exhibits limited shelf-life at room temperature but is stable under refrigeration.
- This study provides critical data for the appropriate storage and use of extemporaneous dapsone suspensions.
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