Quality in Ghanaian pharmaceutical production: a case study of a combination analgesic
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Date
2009-07-11
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Abstract
In the study of a combined analgesic produced in Ghana, the following quality parameters were used in evaluating the oral solid dosage form: 1. Visual appearance, 2. Friability 3. Test of identity 4. Uniformity of weight 5. Test for purity (limit test) 6. Disintegration 7. Dissolution 8. Content of active ingredient. Thirty seven (37) batches of the products selected within four months were used for the study. HPLC was used for the assay of the Aspirin, paracetamol and caffeine combination. In all assay benzoic acid was used as internal standard. Water, methanol and glacial acetic acid in the ratio of (75:25:0.2) by volume at pH 2.98 was used as the mobile phase. The compounds were eluted isocratically using a spherisorb S5ODS1 phase (25cm x 4.6mm) column. The flow rate was 1.3 ml per minute. The detector was set at 298nm with an Absorbance Unit Fraction (AUF) of 0.2. The Limit of Detection (LOD) and Limit of Quantification (LOQ) were established for paracetamol, aspirin, caffeine and salicylic acid to be (15.178 ug /ml and 75.89 ug / ml), (7.0 ug /ml and 35.0 ug / ml), (2.1054 ug /ml and 10.5271 ug / ml) and (0.154 ug /ml and 0.7698 ug / ml) respectively. The compounds were eluted in the following order: paracetamol, salicylic acid, Aspirin, and caffeine. The average retention times were (3.640 ± 0.011) min, (7.668 ± 0.028) min, (9.258 ± 0.030) min and (18.848 ± 0.100) min.
UV spectrophotometric method was used as an alternative method for the assay of the dissolution product. The product was assayed without extraction. Simultaneous equation was used to resolve the spectral overlap caused by the constituent active ingredients in the tablet. The λ maximum and specific absorbance for paracetamol, aspirin and caffeine in the medium 0.01M hydrochloric acidic were 244 nm (A11678.5), 229 nm (A11461.5) and 274 nm (A11497) respectively.
The dissolution profile showed a rapid dissolution rate with 91.87% of the batches having 70% of all their active ingredients going into the dissolution medium within 20 minutes. The rapid dissolution makes quick bioavailability of the active ingredients, enhancing rapid absorption for action.
The weight uniformity test and friability test performed had only few batches failing. Ninety seven (97%) of all the batches used passed the weight uniformity test. Ninety seven point three (97.3%) of the batches passed the friability test with only one batch failing.
The paracetamol content in the tablets had the least standard deviation of 6.4 indicating the least variance within the batches. Eighty six point five (86.5%) of the total batches used had their paracetamol content passing the assay test.
Aspirin had the highest standard deviation (14.36) and therefore was the Component with the largest variation in the batches assayed compared with paracetamol and caffeine with standard deviation of 6.4 and 11.4 respectively.
The caffeine content was found to be higher than the stipulated amount (30mg) in all the batches except one. Ninety seven point three (97.3%) of all the batches used therefore failed the assay test.
Seven (7) out of the 37 batches assayed failed the salicylic acid limit test ,that is they had a percentage salicylic acid content higher than 3.0%.
All other parameters except the following: the excessive caffeine content and high variation in aspirin content were not satisfactory.
Description
A Thesis Submitted to the Department of Pharmaceutical Chemistry Faculty of Pharmacy And Pharmaceutical Sciences College of Health Sciences Kwame Nkrumah University of Science and Technology, Kumasi in Partial Fulfilment of the Requirements for the Degree of Master of Science: Pharmaceutical Analysis And Quality Control,