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Download this complete Project material titled; Comparative Evaluation Of The Ascorbic Acid Content Of Mineral Ascorbate And Ascorbic Acid Tablets Marketed In Zaria with abstract, chapters 1-5, references, and questionnaire. Preview Abstract or chapter one below

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ABSTRACT

The ascorbic acid content of mineral ascorbate and six brands of ascorbic acid tablets marketed in Zaria with brand names Calcium ascorbate, Ascorbion, Emvit C, Ascorvite, Topcee, Bioracee and Sofa C respectively were comparatively evaluated using four methods. These include titrimetric method of British pharmacopoiea 2009, sodium thiosulphate titrimetric method, Ultra violet spectrophotometric method employing stabilizers and a newly developed 2,4-dinitrophenyl hydrazine method. The developed method was validated and the analyte showed an absorption maxima at 527nm and a percentage recovery of 97.4%. Beer‘s law was obeyed in the concentration range of 5ug to 25ug/ml, giving a regression equation of y= 0.041x + 0.032 and a correlation coefficient of 0.9910. The percentage content of ascorbic acid in Calcium ascorbate, Ascorbion, EmvitC, Ascorvite, Topcee, Bioracee, and SofaC in the Ultra violet spectroscopy method using stabilizers were 108.2%, 29.7%, 26.3%, 33%, 66.7%, 46.7%, 27.948% respectively. The values obtained from the sodium thiosulphate titrimetric method were 95.6%, 98.30%, 101.90%, 94.86%, 94.18%, 98.89% and 100.02% respectively. The results obtained from the B.P 2009 titrimetric method were 100.58%, 102.49%, 108.51%, 100.12%, 79.29%, 102.05% and 104.84% respectively, while that of the modified 2,4-dinitrophenyl hydrazine method were 100.47%, 101.99%, 107.898%, 99.83%%, 78.02%, 101.97%, 104.96% respectively. These results obtained showed that the UV spectrophotometric method gave values below the normal range. The values from the sodium thiosulphate titrimetric method was within the normal range but does not compare favourably with the official method, whereas the values for the modified 2,4 dinitrophenylhydrazine method and that of the B.P 2009 titrimetric method were both within the normal range and compared favourably with each other. Both results subjected to Student‘s T-testing showed no significant difference at P value 95% confidence interval (p=0.05). The B.P 2009 titrimetric method showed that there is one substandard product, which is Sofa C on the basis that it has a percent label claim not within 90±5%. The findings of this work further showed that the newly modified method can be used as a substitute for the official method.

 

 

TABLE OF CONTENTS

Title Page- – – – – – – – – – -i Declaration- – – – – – – – – – -ii Certification- – – – – – – – – – -iii Acknowledgements – – – – – – – – – -iv Abstract- – – – – – – – – – – v Table of Content – – – – – – – – – -vi List of Table – – – – – – – – – – -xi List of Figure – – – – – – – – – -xiii Abbreviations – – – – – – – – – -xiv CHAPTER ONE 1.0 Introduction- – – – – – – – – 1 1.1 Ascorbic acid – – – – – – – – 1 1.2 Statement of research problem – – – – – – 4 1.3 Justification of study- – – – – – – – 4 1.4 Research hypothesis- – – – – – – – 4 1.4.1 Null- – – – – – – – – 4 1.4.2Alternative hypothesis- – – – – – – – 5 1.5 Aims and objectives – – – – – – – 5 1.5.1 Aims- – – – – – – – – – 5
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1.5.2. Specific Aims and objectives – – – – – – 5 Chapter Two Literature Review – – – – – – – – 6 2.1 Chemistry of ascorbic acid – – – – – – 6 2.2. Drug indications of ascorbic acid – – – – – 6 2.3. Caution – – – – – – – – – 7 2.4. Pharmacokinetics of Ascorbic acid – – – – – 7 2.5. Mode of action of ascorbic acid – – — – – – 7 2.6. Interactions of Ascorbic Acid – – – – – – 8 2.7. Other importance of ascorbic acid – – – – – 8 2.8. Synthesis of ascorbic acid – – – – – – 9 2.9. Oxidation of ascorbic acid – – – – – – 12 2.10. Calcium ascorbate – – – – – – – 14 2.11. General approach to pharmaceutical analysis – – – – 14 2.11.1 Physiocochemical methods – – – – – – 15 2.11.1.1 Titrimetric method – – – – – – – 15 2.11.1.2 Gravimetric method – – – – – – – 16
2.11.1.3. Chromatographic method – – – – – – 17
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2.11.1.4. UV spectrophotometric method – – – – – 18 2.11.1.5. Infrared spectrophotometric method – – – – 21 2.11.2. Biological methods – – – – – – – 22 2.11.2.1. Bioassay method – – – – – – – 22 2.11.2.2. Microbiological method – – – – – – 23 2.11.2.3. Radio Immunoassay – – – – – – – 23 2.11.2.4. Sterility test – – – – – – – – 25 2.11.3. Biopharmaceutical methods – – – – – – 26 2.11.3.1. Particle size analysis – – – – – – 26 2.11.3.2. Disintegration – – – – – – – 26 2.11.3.3. Dissolution rate – – – – – – – 27 2.11.3. Friability determination – – – – – – 27 2.12. Selectivity – – – – – – – – 28 2.13. Sensitivity – – – – – – – – 28 2.14. Reliability – – – – – – – – 28 2.15. Methods of ascorbic acid analysis – – – – – 29 2.15.1. HPLC- – – – – – – — – – 29
2.15.2. Enzymatic method – – – – – – – 30
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2.15.3. Fluorometric method – – – – – – – 31 2.15.4. Titrimetric method – – – – – – – 32 2.15.5. Spectrophotometric method – – – – – – 33 Chapter Three 3.0 Materials and methods.- – – – – – – – 36 3.1 Materials.- – – – – – – – – -36 3.1.1 Equipment- – – – – – – – – -36 3.1.2 Reagents- – – – – – – – – -36 3.1.3 Test samples- — – – – – – – – -36 3.2 Methodology- – – – – – – – – -38 3.2.1 Preparation of reagents- – – – – – – – -38 3.2.1.1 0.05 M iodine solution- – – – – – – -38 3.2.1.2 Standardization of iodine solution- – – – – – -38 3.2.1.3 Preparation of 0.1 m thiosulphate solution- – – – – -38 3.2.1.4 Standardization of 0.1 m thiosulphate solutions- – — -39 3.2.1.5 Preparation of 0.01m potassium iodate- – – – – -39 3.2.1.6 Preparation of starch solution (indicator)- – – – — 39 3.2.1.7.Preparation of 0.04% sodiumthiuosulphate- – – – – -39
3.2.1.8 Preparation of 2, 4-dinitrophenylhydarzine solution- – – -39
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3.2.1.9 Preparation of 3% bromine water- – – – – – -40 3.2.1.10 Preparation of 10% thiourea- – – – – – -40 3.2.1.11.Preparation of 4.5 m sulphuric acids (100ml)- – – – -40 3.2.1.12 .Preparation of 85% sulphuric acid (50ml)- – – – – -40 3.2.2.B.P 2009 official method- – – – – – – -40 3.2.3.UV spectrophotometric method using stabilizers- – – – -41 3.2.4.Sodium thiosulphate tirimetric method- – – – – -41 3.2.5. Developed 2, 4-dinitrophenylhydrazine method- – – – -41 3.2.5.1 Method development- – – – – – – -41 3.2.5.2 Reaction- – – – – – – – – -42 3.2.5.3 Determination of wavelenght of maximum absorption- – – -43 3.2.5.4Method application- – – – – – – – -44 Chapter Four 4.0 Results- – – – – – – – – – -45 4.1.0 Calibration curve- – – – – – – – -47 4.1.1 Linearity- – – – – – – – – -47 4.2 Precission study- – – – – – – – – -49 4.3 Accuracy- – – – – – – – – -52 4.4 Percentage recovery- – – – – – – -54
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4.5 Limit of detection- – – – – – – -56 4.7 Limit of quantitation- – – – – – – -57 Chapter Five 5.0 Discussion of results- – – – – – – -61 5.1 Conclusion- – – – – – – – –63 5.2 Recommendation- – – – – – – -64 References- – – – – – – – — -65 Appendix – – – – – – – – – –71

 

 

CHAPTER ONE

INTRODUCTION
1.1 ASCORBIC ACID
Vitamin C otherwise known as ascorbic acid is a water soluble vitamin that is naturally present in some foods, added to others and taken as a dietary supplement. Though it is derived from glucose, humans and some other primates like guinea pigs, teleost, fishes, bats and birds cannot synthesize it invivo due to the genetic mutation that prevents them from synthesizing L-gluconolactone oxidase enzyme, which converts glucose to ascorbic acid. Vitamin C can be synthesized by some other animals like dogs, goats, sheep, etc. (Storn, 1972). Vitamin C is an important component of a healthy diet. Its history revolves around that of the human scurvy disease; a severe form of vitamin C deficiency, probably the first human sickness to be recognized as a deficiency disease. Its symptoms includes exhaustion, massive haemorrhaging of flesh and gums, general weakness and diarrhoea. Presently, it is rare to be seriously deficient of vitamin C, although evidence suggests that many people may have low levels of Vitamin C. Smoking cigarettes lowers the amount of vitamin C in the body. Smokers are therefore at a higher risk of its deficiency. (retrievded from national institute of health, United States). Vitamin C is needed for the growth and repair of tissues in all parts of the body. It helps the body make collagen; an important protein used to make skin, cartilage, tendons, ligaments and blood vessels. It is also needed for healing of wounds and maintenance of bones and teeth.(Briggs, 1981).
In recent years, the determination of ascorbic acid has become an important subject. This is because of the important role it plays in maintaining human health. (Chen and Sato, 1995).
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One of the most intensely studied areas of vitamin C benefits is in the area of cardiovascular health. Researchers are finding that vitamin C impacts several aspects of cardiac health, ranging from blood pressure to endothelia health. As the relationship between oxidative damage, inflammation and atherosclerosis becomes increasingly investigated by science, vitamin C is seen as a key protective element against the aspects of cardiovascular disease. (Forther et al, 2000). Laboratory studies have confirmed that high dosing with vitamin C is cytotoxic to wide range of cancer cell lines and that it boots the anti-cancer activities of several common chemotherapy drugs. In animal models (rats), intra-venous vitamin C has been shown to significantly decrease growth rates of liver, ovarian, pancreatic and globlastoma tumors with dosages easily achievable in humans.(Riordan et al, 2005). Vitamin C has also been shown to have an effect against the HIV virus. A study carried out by Linus Pauling in 1990 clearly showed that the vitamin is very effective in killing HIV virus by inhibiting its replication invitro. (Jeffery, 1995). Also in a report published by Harakeh and Jariwalla in December, 1991, calcium ascorbate and two thiol based reducing agents (glutathione and N-acetyl-L-cysteine) has the ability of reducing extracellular HIV reverse transcriptase an vitamin C does. Mega dosing with vitamin C is known to be able to strengthen the immune system, reduce anxiety and oxidative stress, it is also important for treating opportunistic infections like viral pneumonia and candidiasis. (Cathcart, 1981)
For ascorbic acid tablets to be effective, it must contain active ingredient in conformity to the specifications in official compendia. There has been a lot of report on fake drugs worldwide. (WHO, 1999). Drugs play an important role in improving human health and promoting well-being, however, to produce the desired effect, they have to be safe, efficacious and of
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acceptable quality. The use of ineffective and poor quality drugs will not only endanger therapeutic treatment but also erode public confidence in a country‘s health program. (WHO,1999). In the past few decades, many pharmaceutical industries and distribution channels have flourished throughout the world leading to an increase in the number of products circulating in national and international markets. At the same time, the presence of counterfeit and substandard drugs in those markets has increased substantially as a result of ineffective regulation of the manufacturing and trading of pharmaceutical products by both exporting and importing countries. (WHO 1999). Though in pharmacovigilance, it is often assumed that drug quality and efficacy are assured therefore safety monitoring does not take into consideration the quality of drugs being monitored. For many countries where counterfeit drugs have been reported, it is no longer safe to make this assumption while monitoring safety of medicines, (Akunyili, 2005). Also, empirical observations have shown in Nigeria that there may be more fake than genuine drugs in circulation (Osibo, 1998). According to Adenika, (1998) vitamins are among the most used drugs in Nigeria that have been found to have 70% less of the active ingredient, hence the need for the quantitative evaluation of drugs, particularly vitamins to ascertain their authenticity.
Due to the importance of ascorbic acid in humans, qualitative and quantitative evaluation of ascorbic acid has gained a significant increase in several areas of analytical chemistry such as pharmaceutical analysis. Several analytical methods have been developed. Most of these methods are laborious and some require much reagents that may be either not readily available or are expensive. In a report by Pourmorad et al, (2003), some of the common methods for ascorbic acid analysis have some failures regarding manipulative steps, therefore the need to develop a simple, sensitive, reliable and accurate UV spectrophotometric method for the
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estimation of ascorbic acid in tablet dosage forms that is comparable with existing official method. 1.2. STATEMENT OF RESEARCH PROBLEM. Several methods for ascorbic acid analysis have been developed, most of these methods are laborious and some require much reagents that may be either not readily available or are expensive. In a report by Pourmorad et al, (2003), some of the common methods for ascorbic acid analysis have some failures regarding manipulative steps; therefore the neeed to develop a simple sensitive and accurate UV spectrophotometric method for the estimation of ascorbic acid in tablet dosage forms that is comparable with existing official method. 1.3 JUSTIFICATION OF THE STUDY Vitamins are among the most used drugs in Nigeria (Adenika, 1998). Vitamin C has been reported to be of great value in tackling global health issues of HIV/AIDS and cancer (Cathcart,1981). In view of the widespread use of vitamin C, several methods were developed for the determination of vitamin C in pharmaceutical preparation. According to a report by Pourmorad et al (2003) titrimetric and colorimetric methods commonly used to assay ascorbic acid have some failures regarding manipulative steps. 1.4 RESEARCH HYPOTHESIS 1.4.1 Null Mineral ascorbates and ascorbic acid tablets marketed in Zaria conform to specifications in official compendia
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1.4.2 Alternative hypothesis Mineral ascorbates and ascorbic acid tablets marketed in Zaria do not conform to specifications in official compendia 1.5 AIMS AND OBJECTIVES. 1.5.1 Aim To evaluate the ascorbic acid content of mineral ascorbate and six brands of ascorbic acid tablets 1.5.2 Specific objectives To develop a new spectrophotometric method for determination of ascorbic acid To apply the developed method along with official methods in the determination of percentage content of ascorbic acid in mineral ascorbate and six brands of tablet. To compare the values obtained from the different methods.
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