Advances in Validated Chromatographic Assay of Solid Dosage Forms and Their Drug Dissolution Studies
Pp. 1-43 (43)
Sevinc Kurbanoglu, Ozgur Esim, Ayhan Savaser, Sibel A. Ozkan and Yalcin Ozkan
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.
Analysis, Dissolution, Dosage, Dosage Form, HPLC, Liquid
Chromatography, Mobile Phase, Optimization, Oral Solid Drugs, Pharmaceutical
Technology, Pharmacopeial, Profile, Pharmaceutical, Solid Dosage Forms,
Ankara University, Faculty of Pharmacy, Department of Analytical Chemistry, Tandogan, 06100 Ankara, Turkey.