AbstractThe thesis comprises the study of counterfeit drugs in the Middle East and Subcontinent. An extensive literature review was carried out about counterfeit drugs across the world, consequences of counterfeit drugs and study about various strategies combating counterfeiting.
The thesis concerns the research project aiming the analysis of amoxicillin in counterfeit antibiotics. Various techniques used for the analysis of amoxicillin such as High Performance Liquid Chromatography, Capillary Electrophoresis and Infrared Spectroscopy were also studied in detail for developing ideas and to approach scientifically towards the research on counterfeit drugs.
A suitable method was developed for the CE analysis of amoxicillin in order to achieve better analysis i.e. accurate and repeatable. Amoxicillin was analysed using HPLC and CE and then the results were further confirmed using FT-IR technique.
The results obtained using HPLC and CE are comparable and suggest that almost all the different brands of amoxicillin (excluding sample 10) contained the active ingredients more or less the amount stated by the manufacturers and did not show counterfeiting. Different brands of amoxicillin were found to contain active ingredients within the internationally acceptable limits i.e. a sample tablet or capsule of 500 mg should not contain less than 90 % of active ingredients of the stated amount and similarly no sample should contain more than 120 % of the stated amount (United State’s Pharmacopoeia). Although all the samples show repeatability within the same sample capsule, still a variation in content uniformity is observed between different sample capsules within the same brand of amoxicillin.
The comparison of results obtained from the analysis of all different brands of amoxicillin show the difference of quantity of amoxicillin found in the sample v capsules of the same weight between the different brands but it also show the difference between results obtained for different capsules of the same brand (variation of content uniformity within a particular brand).
Sample 10 was highly suspected to be a counterfeit sample as one of the sample capsules (sample capsule 10a) did not contain any amoxicillin at all. These results were confirmed when sample capsule 10a was repeatedly analysed using HPLC and CE. The results produced by sample capsule 10a after each analysis on HPLC and CE were the same such that no peak was found for sample 10a after several repeated analysis using HPLC and CE techniques.
Further analysis of a 4th capsule (capsule 10d) from sample confirmed that it contained almost the same amount of amoxicillin as stated by the manufacturer. Hence, this analysis suggested that the manufacturer of sample 10 might have produced the antibiotic meeting the international standards of quality control and the counterfeiting might have come from any point along the distribution chain of this product.
|Date of Award||2009|
|Supervisor||Sukhvinder Phull (Supervisor), Robert Morrow (Supervisor) & Alan Greenwood (Supervisor)|
- counterfeit antibiotics
- Middle East