Evaluation of the Quality Assurance of Five Brands Amoxicillin Trihydrate Capsules Sold in the Open Drug Market at Nsukka

Evaluation of the Quality Assurance of Five Brands Amoxicillin Trihydrate Capsules Sold in the Open Drug Market at Nsukka.

ABSTRACT

The active drug content and weight uniformity of five brands (A – E) of Amoxicillin Trihydrate capsules in Nsukka open drug market were evaluated to ascertain their quality assurance using UV visible spectroscopy and gravimetry.

This study has shown that all the brands analyzed showed significant variations with respect to active drug content determination for the three brands B, D and E.

Using United State Pharmacopoeia (USP) and British Pharmacopoeia (BP) specifications of 90 – 110 %, the values obtained were B – (413.525 mg), D – (440.325 mg), E – (414.100 mg). These values were within the general drug acceptance limit of 80 – 110

% but failed the antibiotic amoxicillin trihydrates USP and BP specifications with acceptable limit  of 90 – 110 % determined at  266 nm.  The percentage mean content  of all the brands (A –E) were 77.64, 82.80, 74.24, 88.07 and 82.82.

All the brands passed the weight uniformity test with coefficient of variation CV value range of ± 0 – 5 % for capsules more than 250 mg according to USP and BP specifications.

However, with the result obtained, the consequences are that it poses a serious threat to the health of the entire people of West Africa sub regions that depend on these drugs for therapeutical response.

As all the drugs assayed were below the acceptance limit requirement of antibiotic amoxicillin trihydrate and thus, can lead to serious health implications such as drug resistance, cardiac failure, etc.

Drug regulatory bodies should be at alert and they should conduct strict routine check on all the NAFDAC satisfied companies as all the drugs analyzed compromise their quality because of profit reasons.

TABLE OF CONTENTS

Title Page – – – – – – – – – – – i
Certification Page – – – – – – – – – – ii
Dedication – – – – – – – – – – – iii
Acknowledgement – – – – – – – – – – iv
Table of Contents – – – – – – – – – – v
Abstract – – – – – – – – – – – vi

CHAPTER ONE

1.0 Introduction – – – – – – – – – – 1
1.1 Antibiotics – – – – – – – – – – 1
1.2 Modern Antibiotics – – – – – – – – – 1
1.3 Fake Drug – – – – – – – – – – 2
1.4 Drug regulatory And Enforcement Agent – – – – – – 3
1.5 Drug Professionals – – – – – – – – – 4
1.6 Informal Drug Sellers – – – – – – – – – 5
1.7 Dangers Associated With Purchasing from informal drug sellers – – 6
1.8 Aims and Objectives – – – – – – – – – 7

CHAPTER TWO

2.0 Literature review – – – – – – – – – 8
2.1 Amoxicillin Trihydrate – – – – – – – – – 8
2.2 Properties of Amoxicillin Trihydrate – – – – – – – 8
2.3 β- Lactam Antibiotics – – – – – – – – 10
2.4 Amoxicillin Capsule – – – – – – – – 11
2.5 Medical Uses of Amoxicillin Trihydrate – – – – – – 17
2.6 Side Effect of Amoxicillin Trihydrate – – – – – – – 18
2.7 Instrumentation Method of Analysis – – – – – – 18
2.7. 1 High Performance Liquid Chromatography – – – – – – 18
2.7.2 Operation – – – – – – – – – – 19
2.7.3 Partition Chromatography – – – – – – – – 20
2.7.4 Normal-Phase Chromatography – – – – – – – 21
2.7.5 Displacement Chromatography – – – – – – – 22
2.7.6 Reversed – Phase Chromatography – – – – – – – 23
2.7.7 Sized- Exclusive Chromatography – – – – – – – 25
2.7.8 Ion – Exchange Chromatography – – – – – – – 26
2.8 Voltammetry – – – – – – – – – – 27
2.8.1 Theory – – – – – – – – – – – 28
2.9 Liquid Chromatography – Mass Spectrometry – – – – – – 29
2.9.1 Liquid Chromatography – – – – – – – – 29
2.9.2 Flow Splitting – – – – – – – – – – 30
2.10 Electrospray Ionization — – – – – – – – 31
2.10.1 Ionization Mechanism – – – – – – – – 31
2.10.2 Variants – – – – – – – – – – 31
2.10.3 Applications – – – – – – – – – 32
2.10.4 Noncovalent Gas Phase Interations – – – – – – – 32
2.11 Diferential scanning Calorimetry – – – – – – – 33
2.11.1 Detection Phase Transition – – – – – – – – 33
2.11.2 DTA – – – – – – – – – – – 34
2.11.3 DSC Curves – – – – – – – – – – 34
2.11.4 Applications – – – – – – – – – – 34
2.11.5 Polymers – – – – – – – – – – 35
2.11.6 Liquid Crystals – – – – – – – – – 36
2.11.7 Oxidative Stability – – – – – – – – – 36
2.11.8 Safety Screening – – – – – – – – – 36
2.11.9 DSC in Drug Analysis – – – – – – – – 37
2.11.10 General chemical analysis – – – – – – – 37
2.12 Review of Some of the Works Assayed On Drug Analysis – – – 37
2.13 Ultraviolet Spectroscopy – – – – – – – – 39
2.13.1 Physical Methods of Analysis – – – – – – – 39
2.13.2 Spectrophotometry – – – – – – – – – 41
2.13.3 Terms Used In UV Spectroscopy – – – – – – – 42
2.14 Absorption Laws – – – – – – – – – 45
2.14.1 Instrumentation – – – – – – – – – 46
2.14.2 Light Sources — – – – – – – – – 48
2.14.3 Cells – – – – – – – – – – – 48
2.14.4 Routine Methodology in Spectrophotometric Analysis – – – – 48

CHAPTER THREE

3.0 Materials and Methods – – – – – – – – – 49
3.1 Materials – – – – – – – – – – – 49
3.2 Methods – – – – – – – – – – – 49
3.2.2 Active Drug Content Determination – – – – – – – 49
3.3 Weight Uniformity Test — – – – – – – – 50

CHAPTER FOUR

4.0 Results and Discussion – – – – – – – – – 51
4.1 Results – – – – – – – – – – – 51
4.2 Discussion – – – – – – – – – – 63

CHAPTER FIVE

5.0 Conclusion – – – – – – – – – – 64
References – – – – – – – – – – – 74

 INTRODUCTION

 1.1 ANTIBIOTICS

An antibiotic is a compound or substance that kills or slows down the growth of bacteria ^[1]. The term is often used synonymously with the term antibacterial.

However, with increased knowledge of the causative agents of various infectious diseases, antibiotic(s) has come to denote a broader range of antimicrobial compounds, including antifungal and other compounds ^[2].

It can be loosely defined as the variety of substances derived from bacterial sources (microorganisms) that control the growth of or kill other bacteria.

However, synthetic antibiotics, usually chemically related to natural antibiotics, have since been produced that accomplish comparable tasks.

1.2 Modern antibiotics

The term “antibiotics” was coined by Selman Waksman in 1942 to describe any substance produced by a micro-organism that is antagonistic to the growth of other micro-organism in high dilution ^[3].

This definition excluded substances that kill bacteria, but are not produced by microorganisms (such as gastric juices and hydrogen peroxide). It also excluded synthetic antibacterial compounds such as the sulphonamides.

Many antibiotics are relatively small molecules with a molecular weight less than 2000 atomic mass units ^[3].

REFERENCES 

Dorlands Medical Dictionary:antibacterial. (2008), Archived from the original on http://www.mercksource.com/pp/us/cns/cns_hl_dorlands_split.jsp?pg=/ppdocs/u s/common/dorlands/dorland/one/000005889.htm.  Retrieved 2010-10-29

Waksman, S.A. (1947), What Is Antibiotic or an Antibiotic Substance. Pp. 565–569.

Von Nussbaum, F. (2006), Medicinal Chemistry of Antibacterial Natural Products – Exodus or Revival?”. Angew. Chem. Int. Ed. 45 (31): 5072–5129

Calderon,C.B., Sabundayo, B.P .(2007), Antimicrobial Classifications: Drugs for Bugs.. ISBN 978-0-8247-4100-6

Zadik, Y., Findler, M., Livne, S, (2008), “Dentists’ knowledge and implementation of the 2007 American Heart Association guidelines for prevention of infective endocarditis”. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 106 (6): e16-9.

Pankey, G.A., Sabath, L.D. (2004), “Clinical relevance of bacteriostatic versus bactericidal mechanisms of action in the treatment of Gram-positive bacterial infections.” Clin Infect Dis. 38 (6): 864–870.