A rapid micro quantification method of paracetamol in suppositories using differential scanning calorimetry

Area of Science:

• Pharmaceutical Sciences
• Analytical Chemistry
• Materials Science

Background:

• Ensuring content uniformity in pharmaceutical suppositories is critical for effective drug delivery and patient safety.
• Traditional methods for determining drug content in suppositories can be time-consuming and require sample extraction.

Purpose of the Study:

• To evaluate Differential Scanning Calorimetry (DSC) as a rapid and accurate method for assessing paracetamol content uniformity in suppositories.
• To compare DSC results with UV spectrophotometry for paracetamol quantification.

Main Methods:

• Small samples (2.5-4.0 mg) from different sections of paracetamol suppositories were analyzed using DSC.
• Paracetamol content was determined from the enthalpy of fusion and expressed as % w/w.
• Statistical analysis (One-way ANOVA, Student's t-test) was employed to compare results.

Main Results:

• Paracetamol suppositories exhibited statistically similar content across tip, middle, and base sections (10.1-10.3% w/w), indicating high-quality manufacturing.
• DSC and UV spectrophotometry yielded statistically equivalent results for paracetamol content (approx. 120.8 mg).
• DSC demonstrated high sensitivity, reproducibility, and a low detection limit, requiring minimal sample mass and no extraction.

Conclusions:

• DSC is a validated, efficient alternative method for determining paracetamol content in suppositories.
• The method is well-suited for rapid content uniformity assessment in quality control (QC) and in-process quality control (PQC).
• The study highlights the capability of DSC for precise pharmaceutical analysis with significant advantages in speed and sample requirement.