Development and Adaptation of New Analytical Procedures for The Analysis of Some Pharmaceutical Combinations

Abstract

The objective of this research project was set to develop and adapt quality assurance methodologies that are compliant with the current good laboratory practices (cGLPs), as stipulated by leading regulatory competent authorities at national (e.g. FDA), regional (EMEA) and international (e.g. ICHIWHO) levels, so as to enable egyptian pharmaceutical industry to compete in a quality-driven global market.

To endover these objectives, highly sensitive and specific HPLC methods for the determination of the active constituents in several multicomponent dosage forms were realized, namely: -

1- Fluoxetine HCI m dosage form, spiked plasma sample and in biological fluids. 2- Determination of certain drugs present in fixed dose multicomponent pharmaceutical preparations without prior separation steps, as: - a- Determination of a mixture of chlorpheniramine maleate and tincture ipeca in certain cough preparations. b- Determination of a mixture of caffeine, ergotamine, propyphenazone, camylofin and mecloxamine in an analgesic preparation. In the course of realizing the above obje,ctives, the followings have been

accomplished:

1- HPLC determination of the selective serotonin reuptake inhibitor, fluoxetine. The method involved chromatography of fluoxetine samples on a Jl Bondapak CIS column using a mixture of acetonitrile:. water: triethylamine (48: 50: 2), the pH of water and triethyl amine was adjusted to 4.7 using phosphoric acid, as mobile phase flowing at 1.5 ml/min and spectrophotometric detection at 228 nm. Pyridoxine HCl was used as internal standard.