Validation of Dissolution Method of Levofloxacin 750 mg Tablet by High Performance Liquid Chromatography

Abstract

Dissolution test is needed to investigate the drug release of dosage form and its performance in vivo. The lot-to-lot quality of drug product is estimated by dissolution test. Research and validation of procedures of dissolution is of utmost significance during formation of new formulation and quality control. The process of dissolution should be adequately formulated and justified. This paper aims to summarize the creation and validation of dissolution procedure/s as well as to propose a feasible method of specificity, linearity, range, accuracy, and precision of the methods and limit of detection and limit of quantitation. Validation and development of dissolution test procedures may be an unwieldy process, in several dimensions. Techniques need to be generated and proven not only of the dissolution test technique per se, but also of some assay to determine the test outcomes [1]. This research aims at establishing, testing, and testing a strong dissolution process of Levofloxacin 750 mg tablets, using RP HPLC. The dissolution process will provide a reflection of what happens in vivo when administering the drug and assist in evaluating quality on a lot-to-lot basis and in the comparability of generic and brand-name products [2].