TABLE OF CONTENTS
DECLARATION .......................................................................................................................................... ii
DDEDICATION ............................................................................................................................................. iii
ACKNOWLEDGEMENT ........................................................................................................................... iv
ABBREVIATIONS ..................................................................................................................... vii
ABSTRACT ............................................................................................................................................... viii
CHAPTER ONE ........................................................................................................................................... 1
I I INTRODUCT!ON ............................................................................................................................... 1
1.11 Background ................................................................................................................................... 1
1.2 Problem statement ........................................................................................................................... 3
1.3 Aim of' the study .............................................................................................................................. 3
1.4 Significance of the study ................................................................................................................. 3
1.5 Objectives of the study .................................................................................................................... 4
I .5 I General objective ...................................................................................................................... .4
I.S:2 Spccilic objeetivcs .................................................................................................................... .4
1.6 Research qucstion ............................................................................................................................ 4
1.7 Inclusion procedure ........................................................................................................................ .4
CHAPTER TWO .......................................................................................................................................... 5
LITERATURE REVIEW .................................................................................................................... 5
2.1\zithromycin ................................................................................................................................... S
2.2 Pharmaceutical equivalence ............................................................................................................ 5
2.3 Friability test ................................................................................................................................... 6
2.4 Weight variation .............................................................................................................................. 6
2.5 liard ness test ................................................................................................................................... 7
2.6 Disintegration test. ........................................................................................................................... ?
CHAPTER THREE ...................................................................................................................................... 8
MATERIALS ND METHODS .................................................................................................. 8
Equipment: I lard ness tester, Friabilator, Disintegration machine, Electronic balance, UV-Vis
spectrophotometer, Mmtar and pestles ................................................................................................. 8
3 .2 Study area ......................................................................................................................................... 8
3.3S tudy design ..................................................................................................................................... 8
3.'11 Inclusion criteria ............................................................................................................................ 8
3.2 Exclusion criteria ........................................................................................................................... 8
3.5 l.aboratory analysis ......................................................................................................................... 8
3.51 Weight variation ............................................................................................................................ 9
3.52 Disintegration tcs\. ....................................................................................................................... 10
3.53 Reliability test ............................................................................................................................... 10
3.5~ llardcst tcs\ .................................................................................................................................. 10
3.55 Assay of the active ingredient ..................................................................................................... 10
3.551 Preparation of standard calibration curvc .............................................................................. 10
3.6 Data analysis ................................................................................................................................. 11
CHAPTER FOUR ...................................................................................................................................... 12
1.1 RESULTS .......................................................................................................................................... 12
1,.11 Weight variation .......................................................................................................................... 12
Table 4: Hardness, friability, and disintegration ........................................................................... 12
CHAPTER FIVE: ......................................................................................................................................... 16
5.1 DISCUSSION ................................................................................................................................... 16
5.2 Weight variation .......................................................................................................................... 16
5.12 Hardness ...................................................................................................................................... 16
S.IJ Disintegration .............................................................................................................................. 16
5.14 Friability ..................................................................................................................................... 17
5.15 Assay ........................................................................................................................................... 17
5.2 CONCLUSION ................................................................................................................................. 17
5.3 RECOMMENDATIONS .................................................................................................................. 17
REFERENCES ............................................................................................................................................ 18
ABSTRACT
Azithromycin, being a very important antibiotic, is manufactured by different pharmaceutical companies and available in numerous brands. Therefore, it requires a quantitative evaluation and assessment of tablets' chemical, and physical properties to determine their pharmaceutical equivalence. In this study, three brands of 500mg azithromycin on the Ugandan market that is: brand X from lJ .K, Y from Egypt, and Z from U.S .A were tested for pharmaceutical equivalence irrespective of their large differences in cost. The physicochemical quality parameters tested included: weight variation, size, hardness, friability and disintegration time of three brands of
