In Vitro Dissolution Profile of Dapagliflozin: Development, Method Validation, and Analysis of Commercial Tablets.

Area of Science:

• Pharmaceutical Sciences
• Analytical Chemistry

Background:

• Dapagliflozin, a sodium-glucose cotransporter inhibitor, is a recently approved medication requiring robust analytical methods for quality assurance.
• Dissolution studies are crucial for evaluating the quality and performance of pharmaceutical tablets.

Purpose of the Study:

• To develop and validate a spectrophotometric method for dapagliflozin quantification in tablets.
• To establish a dissolution methodology for dapagliflozin tablets.
• To assess the quality and similarity of commercial dapagliflozin tablets.

Main Methods:

• Dissolution testing using USP Apparatus II (paddle) in simulated gastric fluid (pH 1.2) at 37°C and 50 rpm.
• Spectrophotometric quantification at λ = 224 nm.
• Method validation including specificity, linearity, precision, accuracy, and robustness (Factorial 2^3 design).

Main Results:

• The spectrophotometric method was specific, linear (r² = 0.998), precise (RSD < 2%), and accurate (recovery 80.72-119.41%).
• The dissolution method was robust (p > 0.05).
• Commercial dapagliflozin tablets (5 and 10 mg) showed similar dissolution profiles.

Conclusions:

• A validated spectrophotometric method and dissolution procedure for dapagliflozin tablets were successfully developed.
• The method is suitable for quality control and can serve as a foundation for official pharmacopoeial methods.
• Commercial dapagliflozin tablets meet quality standards based on dissolution efficiency analysis.