The purpose of this study is to develop a discriminate dissolving method that may be utilised as a release parameter for testing and assessing product performance in regulated markets utilising quality by design trials. Dissolution testing is required for all solid oral dosage forms and is utilised for product release and stability testing throughout the development life cycle. The proper parameters were developed after testing solubility in the dissolution medium, surfactant concentration, rotation speed, dissolution medium pH, and apparatus type. The best dissolution conditions were found using a USP apparatus II, 900 ml of 0.4 percent SLS medium in pH 4.5 acetate buffer, and a 75 rpm rotation speed, according to research. Conclusion: This study demonstrates the methodical development of a discriminate dissolution method for Rivaroxaban, a BCS Class 2 medication with pH-independent solubility. The dissolution method described here can be used to perform a quality control test on Rivaroxaban tablets, with an emphasis on batch to batch comparisons.
Author(s) Details
Pankaj Mandpe
Micro Labs Ltd., Andheri (E), Mumbai, India.
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