A COMPARATIVE PHARMACOPEIAL ANALYSIS OF THREE BRANDS OF VITAMIN C TABLETS AVAILABLE IN UGANDA PHARMACIES USING BP 2009

TABLE OF CONTENTS

Contents

DECLARATION ......................................................................................................................................... 1

DEDICATION ............................................................................................................................................. 2

ACKNOWLEDGEMENT ............................................................................................................... , ........... 3

TABLE OF CONTENTS ........................................................................................................................... 4

List of tables .................................................................................................................................................. 6

List of figures ................................................................................................................................................. 6

LIST OF ABBREVIATIONS .................................................................................................................... 7

ABSTRACT ................................................................................................................................................. 8

CHAPTER ONE ......................................................................................................................................... 9

INTRODUCTION ....................................................................................................................................... 9

1.1 Background ........................................................................................................................................... 9

1.2 Problem statement .............................................................................................................................. 10

1.3 Justification of the study .................................................................................................................... 10

1.4 Objectives of the study .................................................................................................................. 10

1.4.1 General objective ............................................................................................................................. 10

1.4:2 Specific objectives ............................................................................................................................ 11

1.5 Research questions .............................................................................................................................. 11

CHAPTER TWO ...................................................................................................................................... 12

LITERATURE REVIEW ........................................................................................................................ 12

2.1 Overview about tablets ....................................................................................................................... 12

2.2 Vitamin C tablets ................................................................................................................................ 13

2.3 Characteristics of vitamin C tablets .................................................................................................. 14

2.4 Effects of vitamin C ............................................................................................................................ 14

2.5 Identification of vitamin C ................................................................................................................. 14

2.5.1 Hardness test .................................................................................................................................... 14

2.5.2 Friability test .................................................................................................................................... 15

2.5.3 Dissolution test ................................................................................................................................. 15

2.6 Quality of drugs sold in the pharmacies ........................................................................................... 16

CHAPTER THREE .................................................................................................................................. 17

MATERIALS AND METHOD ....... ., ...................................................................................................... 17

3.1 Area of study ....................................................................................................................................... 17

3.2 Study design ......................................................................................................................................... 17

3.3 Determination of sample size ............................................................................................................. 17

3.4 Selection criteria .................................................................................................................................. 17

3.4.1 Inclusion criteria .............................................................................................................................. 17

3.4.2 Exclusion criteria ............................................................................................................................. 17

3.5 Laboratory analysis ............................................................................................................................ 17

3.5.1 Weight variation test ........................................................................................................................ 18

3.5.2 Disintegration test ............................................................................................................................ 18

3.5.3 Tablet friability test ......................................................................................................................... 18

3.5.4 Hardness test .................................................................................................................................... 18

3.5.5 Dissolution test ................................................................................................................................. 19

3.5.6 Identification test ............................................................................................................................. 19

3.5. 7 Ascorbic acid assay .......................................................................................................................... 19

3.5.8 Limit test ........................................................................................................................................... 19

3.6 Data analysis ........................................................................................................................................ 20

3.7 Ethical considerations ......................................................................................................................... 20

3.8 Limitations to the study ...................................................................................................................... 20

CHAPTER FOUR ..................................................................................................................................... 21

4.0 RESULTS ...................................................................................................................................... 21

CHAPTER FIVE ...................................................................................................................................... 28

REFRENCES ............................................................................................................................................ 32 

ABSTRACT 

Background: There has been a lot of report on fake drugs worldwide and Vitamin C is no exception. Aim: This study was aimed at investigating whether the selected brands of vitamin C meet their label specifications as well as the BP 2009. 

Materials and Methods: Three brands of Vitamin C were randomly selected in Pharmacies of Ishaka-Bushenyi Municipality, Bushenyi. A total of 20 tablets of each brand were chosen and used for this study. Mechanical evaluation on weights, disintegration, fhability, hardness were conducted. Quantitative tests on dissolution and ascorbic acid assays as well as qualitative tests on thin layer chromatography and limit test were done using international protocols. Information was recorded in duplicates and analysis conducted using MS Excel :2007 Version and significance was measured at 95%. 

Results and Discussion: Vitamin C tablets used in this study showed weight variations. Because various brands are produced by different companies which use different excipients. Variations in the weights have to be optimized to improve on tablet strength and integrity and the percentage variation was less than ± 5% deviation as recommended by API and BP. Evaluation of the disintegration time showed that Brand B had the longest disintegration time and this affects drug bio-availability. Tablet dissolution was fastest in Brand C and Brand B had the greatest level of ascorbic acid which was well over the recommended 95% mark. The principal spot in the TLC obtained with the standard solution is similar in position, shape, and color intensity with that in the chromatogram obtained with the solutions for all the brands. No precipitation in all brands was detected against oxalic acid which is a common impurity of ascorbic acid. Conclusion and Recommendations: Vitamin C tablets on the Ugandan market exhibited varying phannaceutical properties thus raising major concerns for drug regulation to limit substandard drugs getting into the country.