Validation of a dissolution method with HPLC analysis for lasofoxifene tartrate low dose tablets

Area of Science:

• Pharmaceutical analysis
• Analytical chemistry
• Drug development

Background:

• Accurate dissolution testing is crucial for immediate release low dose tablet formulations.
• Global regulatory filings require rigorous method validation.

Purpose of the Study:

• To validate a dissolution method coupled with high performance liquid chromatography (HPLC) analysis.
• To ensure the method meets global regulatory submission requirements.

Main Methods:

• Method validation encompassing specificity, precision, linearity, accuracy, and range.
• Intermediate precision study using experimental design for Japanese regulatory compliance.
• Assessment of filter suitability, solution stability, and method robustness using statistical design of experiments.

Main Results:

• All validation parameters, including specificity, precision, linearity, accuracy, and range, were met.
• Intermediate precision and robustness studies confirmed method reliability.
• Standard and sample solution stability were demonstrated.

Conclusions:

• The validated dissolution-HPLC method is suitable for the immediate release low dose tablet formulation.
• The method fulfills requirements for global regulatory filings.
• The established analytical procedure ensures product quality and consistency.