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.

CHAPTER ONE
1.0 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].With advances in medicinal chemistry, most antibiotics are now semi synthetic modified chemically form of the original compounds found in nature,[4] as is the case with beta-Lactams (which include the penicillins, produced by fungi in the genus penicillium, the cephalosporins, and carbapenems). Some antibiotics are still produced and isolated from living organisms, such as the amino glycosides and others have been created through purely synthetic means, the sulphonamides, the quinolones, and the oxazolidinones[4]. In addition to this origin-based classification into natural, semi synthetic, and synthetic, antibiotics may be divided into two broad groups according to their effect on micro-organisms. Those that kill bacteria are bactericidal agents, whereas antibiotics are commonly classified based on their mechanism of action, chemical structure, or spectrum of activity [4]. Most antibiotics target bacterial functions or growth processes. Antibiotics that target the bacterial cell wall (penicillin, cephalosporins), or cell membrane (polymixins), or interfere with essential bacterial enzymes (quinolones, sulphonamides) are usually bactericidal in nature. Those that target protein synthesis, such as the amino glycosides, macrolides and tetracyclines are usually bacteriostatic. Further categorisation is based on their target specificity.

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