Advances in Validated Chromatographic Assay of Solid Dosage Forms and Their Drug Dissolution Studies

Solid dosage forms are the most common drug delivery systems because they provide reproducible and convenient delivery and they are cost effective. It is possible to use immediate, controlled or extended release systems for therapy using solid dosage form such as tablets, capsules, powders, suppositories and lozenges. Solid dosage forms depend on physical properties of the active substance and excipients. To design an effective system and to enlighten the effectiveness, it is important to determine the critical parameters both in pharmacopeia analysis and scientific studies. These critical parameters are various from active substance stability and purity to its in vivo profile in dosage form. The primary objective to identify these parameters is developing a fast and fully validated method. Liquid chromatographic techniques are very suitable and accurate way to determine the content of a pharmaceutical ingredient and its stability both in in vitro and in in vivo systems. Mobil phase composition, flow rate & column choice directly affect the quality of separation in pharmaceutical analysis. In validation of chromatographic methods, validation parameters should be reported in detail. In this chapter, we will discuss solid dosage forms analyses using high performance chromatographic techniques, in terms of their validation parameters and system suitability tests.

Keywords: Analysis, Dissolution, Dosage, Dosage Form, HPLC, Liquid Chromatography, Mobile Phase, Optimization, Oral Solid Drugs, Pharmaceutical Technology, Pharmacopeial, Profile, Pharmaceutical, Solid Dosage Forms, Validation.