DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHODS FOR THE DETERMINATION OF RISPERIDONE IN PURE AND TABLET DOSAGE FORMS


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TABLE OF CONTENTS

Title Page
Abstract
Table of Contents
Abbreviation

CHAPTER ONE
1.0 INTRODUCTION
1.1 Preamble
1.2 Research Problem
1.3 Justification of Study
1.4 Theoretical Framework
1.5 Aim and Objectives
1.6 Research Hypothesis

CHAPTER TWO
2.0 LITERATURE REVIEW
2.1 Psychosis
2.1.1. Definition
2.1.2 Aetiology of schizophrenia
2.1.3. Treatment of schizophrenia and related psychoses
2.2 Risperidone
2.2.1 Overview
2.2.2 Physical properties
2.2.3 Chemistry of risperidone
2.2.4 Benzisoxazole and benzisothiazole derivatives
2.2.5 Laboratory synthesis
2.2.6 Mechanism of action
2.2.7 Side effects of risperidone
2.2.8 Drug interactions
2.2.9 The place of risperidone in antipsychotic therapy
2.3 Quantitative Determination of Risperidone
2.3.1 Non- UV analytical techniques
2.3.2 UV analytical techniques
2.4 Principles of UV Spectroscopy
2.4.1 Introduction
2.4.2 Molecular electronic structure
2.4.3. Electronic absorption spectra
2.4.4 Factors influencing absorption of radiant energy
2.4.5 Laws of light absorption
2.4.6 Intensities of spectral bands
2.4.7 Instrumentation
2.4.8 Instrument configuration
2.5 Dyes
2.5.1 Bromocresol green
2.5.2 Thymol blue

CHAPTER THREE
3.0 MATERIALS AND METHODS
3.1 Materials
3.1.1 Drugs and reference standards
3.1.2 Equipment and glassware
3.1.3 Chemicals and reagents
3.2 Methods
3.2.1 Optimization of variables
3.2.2 Preparation of solutions and reagents
3.2.3 Determination of λ max
3.2.4 Determination of stoichiometry of ion-pair complex
3.2.5 Identification and assay of risperidone (Official methods)
3.2.6 Calibration curves
3.2.7 Validation of methods
3.2.8 Assay of risperidone tablets using developed methods

CHAPTER FOUR
4.0 RESULTS
4.1 Optimization of Variables
4.2 Stoichiometry of Ion-pair Complex
4.3 Calibration Curves
4.4 Validation of Methods
4.5 Assay of Risperidone Tablets
4.6 Statistical Analysis

CHAPTER FIVE
5.0 DISCUSSION

CHAPTER SIX
6.0 CONCLUSION
REFERENCES
APPENDICES



ABSTRACT

Two simple, sensitive, accurate and extraction-free spectrophotometric methods were developed and described for the determination of risperidone in pure and in tablet dosage forms. The methods are based on the formation of ion-pair complex between risperidone and the dyes bromocresol green in method A and thymol blue in method B at room temperature to form yellow coloured products having absorption maxima at 414 nm and 404 nm respectively. The composition of the ion-pairs was established by Job‟s method and it was found to be 1:1 for both methods. Different variables affecting the reaction conditions such as diluting solvents, concentration of dye, reaction time were studied and optimized. Under the optimal conditions, linear relationship with good correlation coefficients (0.994 and 0.995 for methods A and B respectively) was found between

absorbance and the concentrations of risperidone in the range of 2-20 µg/ml and 20-40

µg/ml respectively. The assay limits of detection (LOD) and limits of quantification (LOQ)

were 1.27 and 3.84 µg/ml for method A and 7.00 and 21.15 µg/ml for method B. The

precision of both methods did not exceed 15% likewise the percentage relative error was within the accepted range of 1-5%. No interference could be observed from the excipients commonly present in tablet or liquid dosage forms. The methods developed have been

validated and there is no significant difference (P < 0.05) between the methods and the reference (BP) method. The methods can be successfully applied for the analysis of risperidone in pure and tablet dosage forms.



CHAPTER ONE

1.0 INTRODUCTION

1.1 Preamble

Risperidone is a psychotropic (antipsychotic) agent used in the treatment of schizophrenia. The action is mediated through a combination of dopamine Type 2 (D2) and serotonin Type 2 (5HT2) receptor antagonism. It is a selective monoaminergic antagonist with high affinity for 5HT2, D2 and H1 histaminergic receptors (Potter and Hollister, 2001). It belongs to the chemical class of benzisoxazole derivatives. The chemical name of risperidone is 3-[2-[4-(6-fluoro-1, 2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6, 7, 8, 9-tetrahydro-2-methyl-4H-pyrido-[1,2-a]-pyrimidin-4-one) while the molecular formula is C23H27FN4O2 with the molecular weight of 410.49g (The Merck Index, 2001).

According to the British Pharmacopoeia (2009), risperidone contains not less than 99.0 per cent and not more than the equivalent of 101.0 per cent of 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a] pyrimidin-4-one, calculated with reference to the dried substance (BP, 2009). The absolute oral bioavailability of risperidone is 70% and a half life of 20 hours. It is rapidly distributed
 

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