Analysis of some cosmeceutical preparations

Abstract

This thesis aims to develop reliable, validated, and quantitative methods for the determination of the following antiseptic agents: Hexamidine diisethionate, Chlorhexidine Digluconate, and p-Chlorcresol in various dosage forms including mouthwash and intimate douche in addition to chlorhexidine determination in spiked human saliva. Moreover, the antifungal agent, Piroctone Olamine, was assessed and studied in its pure form and pharmaceutical formulations. This thesis consists of six parts Part I: General introduction This Part is an introduction to cosmeceuticals, their general definition, their classifications, and examples of different cosmeceuticals including the antifungal agents, the antiseptics under investigation, and their mechanism of action. Part II: Literature review The chemical and physical properties of the four investigated drugs are described in this part. It also includes a summary of the various methods for analyzing drugs in pure form, mixtures, pharmaceutical formulations, and biological fluids like saliva. Part III: Electrochemical determination; application to multi-ingredient formulation This part involves the development of simple, reliable, validated, and quantitative methods for the determination of Chlorhexidine Digluconate, in its pure form, in various dosage forms including mouthwash and intimate douche and CHX determination in spiked human saliva. Piroctone Olamine was also determined in various dosage forms. No sample pre-treatment was needed. This part consists of two sections: Section A: Disposable Electrochemical Sensors for Chlorhexidine Determination in Pharmaceutical Formulations and in Spiked Human Saliva Two potentiometric sensors (sensors I and II) were developed based on carbon screen-printed electrodes (SPEs). An ionophore, i.e., 2-hydroxypropyl-β-cyclodextrin was doped into the PVC polymeric membrane to enhance sensor selectivity. Graphene nanocomposites (Gr-NC) were utilized as an ion-to-electron transducer in the fabrication of sensor II which resulted in a stable potential and excluded the formation of a water layer at the interface between the screen-printed electrode (SPE) and the sensing membrane. The sensors had shown a Nernstian slope of 29.0 and 28.8 mV/decade over the linear concentration range of 1.00 x 10-6 – 1.00 x 10-3 M of CHX and a detection limit of 6.56 x 10-7 M and 4.76 x 10-7 M for sensors I and II, respectively. Such a potentiometric method requires no pre-treatment and manipulation of the sample without any interferences from the matrix of saliva or the excipients in the dosage forms and other interfering species. Greenness assessment of the proposed method was performed. Section B: Voltammetric determination of piroctone olamine in Pharmaceutical Formulations In this section, Cyclic voltammetry (CV) and Differential pulse voltammetry (DPV) were applied. The method was applied for the determination of PCT in various pharmaceutical formulations such as Caudal® and Fast Care-D® shampoo with good accuracy and recovery. Part IV: Chromatographic determination of drug combination and applications to several pharmaceutical formulations This part involves simple, reliable, validated, and quantitative chromatographic analytical methods for (HEX), (CHX), and (CSOL) determination in various dosage forms including mouthwashes and intimate douches in addition to chlorhexidine determination in spiked human saliva. HEX, CHX, and CSOL were determined in colored aqueous formulations without any sample pre-treatment or extraction steps.