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In Vitro Drug Dissolution: Alternative Methods01:17

In Vitro Drug Dissolution: Alternative Methods

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Alternative drug dissolution methods include the rotating bottle, intrinsic dissolution test, peristalsis, and the Franz diffusion cell method. The rotating bottle method involves meticulously rotating tightly capped controlled-release beads in a temperature-controlled bath. Periodic decanting of samples allows for residue assay, followed by refilling with fresh medium and testing at various pH levels to emulate the gastrointestinal tract conditions.In contrast, the intrinsic dissolution test...
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In IR spectroscopy of carboxylic acids, the C=O bond shows a characteristic band between 1710 and 1760 cm⁻¹, and the O–H bond exhibits a broad band between 2500 and 3300 cm⁻¹.
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A phase diagram combines plots of pressure versus temperature for the liquid-gas, solid-liquid, and solid-gas phase-transition equilibria of a substance. These diagrams indicate the physical states that exist under specific conditions of pressure and temperature and also provide the pressure dependence of the phase-transition temperatures (melting points, sublimation points, boiling points). Regions or areas labeled solid, liquid, and gas represent single phases, while lines or curves represent...
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Metal ions can be separated from one another by complexation with organic ligands–the chelating agent– to form uncharged chelates. Here, the chelating agent must contain hydrophobic groups and behave as a weak acid, losing a proton to bind with the metal. Since most organic ligands used in this process are insoluble or undergo oxidation in the aqueous phase, the chelating agent is initially added to the organic phase and extracted into the aqueous phase. The metal-ligand complex is...
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Metallic solids such as crystals of copper, aluminum, and iron are formed by metal atoms. The structure of metallic crystals is often described as a uniform distribution of atomic nuclei within a “sea” of delocalized electrons. The atoms within such a metallic solid are held together by a unique force known as metallic bonding that gives rise to many useful and varied bulk properties.
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Solids in which the atoms, ions, or molecules are arranged in a definite repeating pattern are known as crystalline solids. Metals and ionic compounds typically form ordered, crystalline solids. A crystalline solid has a precise melting temperature because each atom or molecule of the same type is held in place with the same forces or energy. Amorphous solids or non-crystalline solids (or, sometimes, glasses) which lack an ordered internal structure and are randomly arranged. Substances that...
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HPLC method with UV detection for evaluation of digoxin tablet dissolution in acidic medium after solid-phase

A Jedlicka1, T Grafnetterová, V Miller

  • 1Léciva a.s., U kabelovny 130, Dolní Mecholupy, 102 37 Prague 10, Czech Republic. jedlicka@leciva.cz

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|August 30, 2003
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Summary

A new method accurately measures digoxin tablet dissolution in hydrochloric acid. This technique, using solid-phase extraction and HPLC, also identifies digoxin degradation products for quality control.

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Area of Science:

  • Pharmaceutical Sciences
  • Analytical Chemistry

Background:

  • Digoxin is a critical cardiac glycoside medication.
  • Ensuring digoxin tablet quality requires reliable dissolution testing.
  • Understanding digoxin degradation is vital for drug stability.

Purpose of the Study:

  • To develop a simple and reliable method for digoxin tablet dissolution evaluation.
  • To analyze digoxin and its degradation products.
  • To confirm the identity of digoxin degradation products.

Main Methods:

  • Dissolution testing in 0.01 M hydrochloric acid.
  • Solid-phase extraction (SPE) using C18 Sep-Pak cartridges.
  • High-Performance Liquid Chromatography (HPLC) analysis on a C18 column.
  • Detection at 218 nm.
  • High-Performance Liquid Chromatography-Mass Spectrometry (HPLC-MS) for identity confirmation.

Main Results:

  • A simple and reliable dissolution method for digoxin tablets was successfully developed.
  • Digoxin and its degradation products were effectively separated and analyzed.
  • The identity of digoxin degradation products was confirmed using HPLC-MS.

Conclusions:

  • The developed method provides a robust approach for digoxin tablet dissolution testing.
  • The method facilitates the identification and characterization of digoxin degradation products.
  • This contributes to improved quality control and stability assessment of digoxin formulations.