ABSTRACT
Tuberculosis (TB) is a serious infectious disease which is on increase since emergence of human immunodeficiency virus (HIV) leading to TB/HIV co infection, causing complications and treatment failure. Isoniazid is a first line drug for the treatment of TB therefore it is important to develop methods that will monitor its quality. In this study, four rapid, simple, relatively accurate, and precise spectrophotometric methods for the quantitative determination of isoniazid in pure and tablet dosage form were developed and validated. Methods 1 and 2 were based on dissolving standard isoniazid powder in distilled water and methanol respectively and scanning using UV-Vis spectrophotometer at a wavelength range of 200 - 400 nm to determine the wavelength of maximum absorption (λmax). Method 3 was based on condensation reaction between isoniazid and 2,4-di-nitrophenyl hydrazine (2,4 DNPH) and heating under acidic condition using 2 mL of 85 % hydrochloric acid (HCl) to form an orange-red hydrazone which was allowed to stand for few minutes for complete color development. Method 4 was based on the diazotization of isonizid with sodium nitrite (NaNO2) and coupling withparaaminotoluidine under acidic condition (2 % HCl) and gently heating to give a colouredchromagen (diazo dye) which was allowed to stand for few minutes for complete color development. The colouredhydrazone and diazo dye formed were scanned at visible range of 400-750 nm to determine their λmaxs. Calibration curves were prepared using these methods. The developed methods were validated using ICH guidelines with respect to linearity, precision, accuracy, percentage recovery, limit of detection (LOD) and limit of quantification (LOQ). Standard isonizid powder and a sample of isoniazid tablet were assayed using each method and compared with BP, 2009 method for the assay of isoniazid. Method 1 and 2 were observed to have a λmax of 264 nm while an orange-red and a yellow chromagencolours were formed for methods 3 and 4 viii with time for complete development and λmax 15 and 20 minutes, 464 and 420 nm respectively. Methods 1 and 2 obeyed Beer’s law within a concentration range of 1-11 μg/mL while the range for methods 3 and 4 was 1-18 μg/mL. The correlation coefficient for the calibration plot was 0.999 in each case. The precision of the methods were ≤ 1.57 (percentage coefficient of variation, % CV) while the accuracy, percentage relative error (% Er) and percentage recoveries were ≤ 4.130 and ≤ 102.01 respectively. The methods have LOD and LOQ of ≤ 0.145 and ≤ 0.559 µg/mL respectively. All the validation parameters were within the normal ranges. The percentage content of isoniazid in the standard powder and brand of the tablet assayed using all the developed methods were within the BP range of 99 - 101 % and 98.0 – 102 % respectively. There was no significant difference (p < 0.05) between the percentages drug content assayed using the developed methods and that of the BP method, thus the developed methods can be interchanged with the BP method for quantitative estimation of isoniazid in pure and tablet dosage form.
Background of the Study
Social media platforms are increasingly used as sources of academic and news information. However,...
Background of the Study
Non-state actors, particularly multinational corporations (MNCs), have emerged as influential playe...
Chapter One: Introduction
1.1 Background of the Study
Rural...
Background of the Study
The preservation and appreciation of historical heritage are crucial for fostering a sense of iden...
Background of the Study
Tax compliance is essential for ensuring adequate revenue generation at the loc...
Background of the Study
Risk management is a fundamental aspect of the banking industry, essential for ensuring the stabil...
Background of the Study
Student engagement is a key factor in determining academic success and enhancing the overall learning experience....
Background of the study
Virtual event marketing has emerged as a transformative tool in engaging audiences, particularly in...
Background of the Study
Technical education in secondary schools is pivotal for nurturing future engineer...
Background of the Study:
Technological advancements have become the cornerstone of productivity enhancement in modern manufacturing secto...