Development and Validation of Discriminative Dissolution Method for Metformin Immediate-Release Film-Coated Tablets.

Area of Science:

• Pharmaceutical Sciences
• Drug Development
• Analytical Chemistry

Background:

• Metformin is a widely used medication for type 2 diabetes.
• Immediate-release metformin formulations require robust dissolution testing for quality assurance.
• Biopharmaceutical Classification System (BCS) Class III drugs present unique dissolution challenges.

Purpose of the Study:

• To develop and validate a discriminative dissolution method for immediate-release metformin film-coated tablets.
• To establish optimal conditions for dissolution testing of metformin.
• To ensure the method's suitability for routine quality control and formulation assessment.

Main Methods:

• Optimization of dissolution medium (phosphate buffer pH 6.8, 1000 mL), apparatus (USP Apparatus II, paddle), temperature (37°C), and rotation speed (75 rpm).
• Quantification of released metformin using UV/Vis spectrophotometry at 232 nm.
• Validation of the method according to international guidelines, assessing specificity, accuracy, precision, linearity, robustness, and solution stability.

Main Results:

• The optimized method using phosphate buffer pH 6.8 and Apparatus II demonstrated discriminative power for metformin tablets.
• Acceptance criteria were set at not less than 75% dissolved within 45 minutes (Q=75% at 45 min).
• The method successfully met all validation parameters, confirming its reliability and suitability.

Conclusions:

• A validated, discriminative dissolution method for metformin film-coated tablets was successfully developed.
• The method can effectively identify variations in product performance and is suitable for routine batch testing.
• This contributes to ensuring the quality and efficacy of metformin formulations.