Cleaning Method Validation for Estimation of Dipyridamole Residue on the Surface of Drug Product Manufacturing Equipment Using Swab Sampling and by High Performance Liquid Chromatographic Technique.

Objectives: Cleaning validation is the procedure used to ensure that the cleaning process has eliminated the residues of drug substance from on the equipment surface after manufacture. A simple, sensitive, robust, and accurate high performance liquid chromatographic method was developed for the quantitative estimation of dipyridamole in swab samples obtained from the equipment surface after the manufacture of dipyridamole modified release capsules.

Materials And Methods: The method was developed by using a Hypersil BDS C18 (150×4.

Analytical Method Development and Validation for the Quantification of Acetone and Isopropyl Alcohol in the Tartaric Acid Base Pellets of Dipyridamole Modified Release Capsules by Using Headspace Gas Chromatographic Technique.

A simple, sensitive, accurate, robust headspace gas chromatographic method was developed for the quantitative determination of acetone and isopropyl alcohol in tartaric acid-based pellets of dipyridamole modified release capsules. The residual solvents acetone and isopropyl alcohol were used in the manufacturing process of the tartaric acid-based pellets of dipyridamole modified release capsules by considering the solubility of the dipyridamole and excipients in the different manufacturing stages. The method was developed and optimized by using fused silica DB-624 (30 m × 0.