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Development and Validation of Spectrophotometric Methods for the Determination of Risperidone in Pure and Tablet Dosage Forms

Development and Validation of Spectrophotometric Methods for the Determination of Risperidone in Pure and Tablet Dosage Forms

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DEDICATION

This research material, titled “Development and Validation of Spectrophotometric Methods for the Determination of Risperidone in Pure and Tablet Dosage Forms” is dedicated to God for His boundless grace and guidance. It is also a tribute to all computer enthusiasts whose contributions made my research journey smoother and enriched my documentation process, making the experience truly fulfilling.



ACKNOWLEDGEMENT

I am profoundly grateful to everyone who contributed to the successful completion of this project. I am especially grateful to my Supervisor (Name), the Head of Department (Name), and the Lecturers in the Department of Pharmaceutical Technology / Science for their invaluable guidance and support. I also acknowledge the contributions of authors and scholars whose works on Development and Validation of Spectrophotometric Methods for the Determination of Risperidone in Pure and Tablet Dosage Forms provided essential insights. Special thanks go to my study area (and any funding organizations, if applicable) for their financial assistance. I am equally thankful to stakeholders, including mentors, teachers, and colleagues, for their encouragement and support. Finally, I deeply appreciate my family and friends for their patience and unwavering support throughout this journey. Your contributions have been instrumental in making this research a reality.



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 20-40µg/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


Development and Validation of Spectrophotometric Methods for the Determination of Risperidone in Pure and Tablet Dosage Forms

CHAPTER ONE

1.1 Introduction

… As a prelude to other parts of this study, this chapter will discuss the background upon which this study was initiated, the statement of problems that led to this study, the Aim and Objectives of the study. Others are Significance of the study, Scope of work, Research hypothesis and questions, Limitation of the study and Definition of technical terms.…

CHAPTER TWO

2.0 Literature Review

2.1 Introduction

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