Liquid chromatographic determination of chlorpropamide in tablet dosage forms: collaborative study

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis
• Chromatography

Background:

• Accurate quantification of active pharmaceutical ingredients (APIs) is crucial for drug safety and efficacy.
• Chlorpropamide is an oral hypoglycemic agent used in diabetes management.
• Existing analytical methods may require optimization for routine pharmaceutical quality control.

Purpose of the Study:

• To develop and validate a robust reverse-phase liquid chromatographic (RPLC) method for chlorpropamide determination.
• To assess the method's linearity, accuracy, and precision in tablet dosage forms.
• To provide an official first action method for chlorpropamide analysis.

Main Methods:

• Development of a reverse-phase liquid chromatography (RPLC) method.
• Establishment of linearity over the 0.2-2.0 microgram range.
• Wavelength detection at 240 nm.
• Recovery studies using synthetic and authentic tablet mixtures.
• Analysis of commercial tablet products (100 mg and 250 mg).

Main Results:

• The RPLC method demonstrated excellent linearity.
• Mean recovery rates were high: 99.2% for synthetic mixtures and 99.6% for authentic mixtures.
• Low relative standard deviations (RSDs) were achieved: 1.41% (synthetic), 0.60% (authentic), 1.24% (250 mg tablets), and 1.24% (100 mg tablets).
• The method was adopted as official first action.

Conclusions:

• The developed RPLC method is accurate, precise, and reliable for quantifying chlorpropamide in tablet formulations.
• This validated method is suitable for routine pharmaceutical quality control and regulatory purposes.
• The official adoption signifies the method's acceptance and utility in the field.