SPECTROPHOTOMETRIC DETERMINATION AND STABILITY STUDIES OF ARTEMETHER IN ARTEMETHER-LUMEFANTRINE SUSPENSIONS MARKETTED IN ZARIA, NIGERIA


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TABLE OF CONTENTS

Abstract
Table of Contents

CHAPTER ONE
1.0 INTRODUCTION
1.1       General Introduction
1.2       Statement of Research Problem
1.3       Justification for the Study
1.4       Aim of the Research
1.5       Specific Objectives
1.6       Research Hypothesis

CHAPTER TWO
2.1 LITERATURE REVIEW
2.0       Artemether as Drug of Analysis
2.1       Properties Of Artemether
2.1.1 IR Spectra of Artemether
2.1.2 Synthesis of Artemether
2.1.3 Mechanism of action of artemether
2.1.4 Pharmacodynamics of artemether
2.1.5 Pharmacokinetics of artemether
2.1.6 Drug Interactions of artemether
2.1.7 Toxicity
2.1.8 Formulations, Dosage and Administration of Artemether
2.2.0 Methods for determination of artemether
2.2.1UV Spectrophotometric Analysis of Artemether
2.2.2 HPLC methods for Artemether determinations
2.3 Absorption Spectroscopy
2.3.1 UV/VIS spectroscopy
2.4 Stability studies
2.4.1 Potential instability issues of FPPs
2.4.2 Stability-indicating quality parameters
2.4.3 Some reported stability studies

CHAPTER THREE
3.0 MATERIALS AND METHODS
3.1 Material
3.1.1 Chemicals and Reagents
3.1.2 Drug samples and drug reference standard
3.1.3 Materials
3.1.4 Instrumentation
3.2 Methods
3.2.1 Preparation of solutions and Reagents
3.2.1.1 Preparation of hydrochloric acid/ethanol (1 mol/l)
3.2.1.2 Preparation of standard stock solution of Artemether in Methanol
3.2.2 Identification and Assay of Artemether (Official methods)
3.2.2.1 Identification of Artemether
3.2.2.2 Assay of Artemether
3.2.3 Method development
3.2.3.1 Determination of λ max
3.2.3.2 Preparation of calibration curve
3.2.3.3 Validation of method
3.2.3.4 Application of the developed method in the assay of Artemether-lumefantrine suspensions
3.3 Stability studies
3.3.1 Preparation of suspensions
3.3.1.1 Preparation of standard artemether suspension
3.3.1.2 Preparation of different brands of artemether/lumefantrine suspensions
3.3.2 Protocol for stability studies

CHAPTER FOUR
4.0 RESULTS
4.1 Identification Tests for Artemether reference standard and powders for suspension
4.1.1 Colour test
4.1.2 melting point
4.1.3 FTIR analysis results
4.2 Method development
4.2.1 Wavelenght of maximum absorption
4.2.2 Calibration curve
4.2.3 Validation of method
4.2.4 Assay
4.3 Stability studies

CHAPTER FIVE
5.0 DISCUSSIONS
5.1 Identification tests
5.2 Method development
5.2.1 Calibration Curve
5.2.2 Validation Parameters
5.2.3 Assay Results and Statistical Analysis
5.3 Stability Studies

CHAPTER SIX
6.0 CONCLUSIONS AND RECOMMENDATIONS
6.1       Conclusions
6.2       Recommendations
            References



ABSTRACT

The increasing use of artemether-lumefantrine combination as an effective treatment for resistant malaria demands the need for analytical methods for the quality control of these drugs in tablets and suspensions. Though some UV Spectrophotometric methods have been developed for quantification of artemether in various biological fluids and formulations, they require strainous heating conditions which is a limitation. This limitation coupled with non-availability of HPLC hence the need to develop and validate a simple method for the quantification of artemether in peadiatric suspensions. In this work, we report the method developed by reacting artemether solution in methanol with concentrated HCl for 30 minutes to obtain an

α,β-unsaturated ketone which was scanned with a UV Spectrophotometer. The method developed obeyed Beers law in the range 20 – 120 µg/ml, slope (y); 0.01 0, intercept (x) 0.193, correlation coefficient (r) 0.9987, λmax 260 nm, precision (%

CV); 2, Accuracy (% Er); 2.67 and a recovery of 97%. The detection and quantification Limit (µg/ml) are 0.14 and 0.58 respectively. The developed method was successfully applied in the assay of five brands of artemether-lumefantrine suspensions with 98-101.6% content, and comparism of the means of the assay results of the method and the IP (2008) method showed no statistically significant difference (P<0 .05="" 14="" 98.5-102="" after="" ambient="" analyzing="" and="" are="" artemether="" be="" between="" bottled="" brands="" by="" carried="" conditions="" content="" could="" days="" developed="" different="" extracting="" five="" for="" from="" in="" interchangeably="" it="" lumefantrine="" methanol="" method.="" method="" of="" out="" over="" period="" powders="" prepared="" ranged="" reconstitution="" results="" showed="" span="" stability="" stable="" standard="" studies="" study="" suggested="" suspension="" suspensions="" table="" that="" the="" this="" under="" upto="" used="" using="" was="" water.="" with=""> analysis, and that co-formulation of artemether with lumefantrine has no effect on the stability of artemether.





CHAPTER ONE

INTRODUCTION

1.2 General Introduction


Malaria is a public health problem (Loset and Kaur, 2009; Karuna et al., 2014). It is an important cause of morbidity and mortality in children and adults in tropical countries.

About half of the world’s population is at risk of this mosquito borne parasitic disease

(WHO, 2010).


Malaria is caused by the protozoan parasite Plasmodium and transmitted by mosquitoes (Shah and Patel, 2012). Five species of the parasite have been shown to infect humans: P. falciparum, P. vivax, P. ovale, P. malariae and P. knowlesi. While they share a basic life-cycle, certain distinctive features relate to the virulence of each species. P. falciparum causes the most severe manifestations of malaria including coma, anaemia and multi organ failure. The severity of P. falciparum infection has been attributed to the relatively high parasitemias during infection and to the adherence of P. falciparum infected erythrocytes to the endothelium of capillaries and venules, a process known as sequestration (Dondorp, 2008)

The main treatments for malaria were inexpensive “monotherapies” such as chloroquine

(Price and Douglas, 2009). Unfortunately, the malaria parasite quickly developed resistance to many of these monotherapies, including amodiaquine, chloroquine, mefloquine, quinine sulphadoxine and pyrimethamine (WHO, 2006). One of the cornerstones of control programs today is the early diagnosis of malaria and its treatment with highly effective drugs. New combination therapies containing artemisinin derivatives are central to this approach, providing practical treatment regimens with high.....


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