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POST MARKET SURVEILLANCE OF MEFENAMIC ACID CAPSULES AND TABLETS RETAILING IN NAIROBI, KENYA

POST MARKET SURVEILLANCE OF MEFENAMIC ACID CAPSULES AND TABLETS RETAILING IN NAIROBI, KENYA. Research by : Khushali Naran Pindoria U29/35778/2010 Supervisor: DR. D.S.B. Ongarora. INTRODUCTION.

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POST MARKET SURVEILLANCE OF MEFENAMIC ACID CAPSULES AND TABLETS RETAILING IN NAIROBI, KENYA

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  1. POST MARKET SURVEILLANCE OF MEFENAMIC ACID CAPSULES AND TABLETS RETAILING IN NAIROBI, KENYA Research by : Khushali Naran Pindoria U29/35778/2010 Supervisor: DR. D.S.B. Ongarora

  2. INTRODUCTION • Poor quality drugs are a major public health problem. • Quality of drugs is more apparent for the widely used therapeutics classes such as NSAIDs (non steroidal anti- inflammatory drugs) • Mefenamic acid is one of the commonly used NSAIDS

  3. OBJECTIVES • Identity tests To carry out identity tests for mefenamic acid capsules and tablets using I R spectrophotometry. • Assay To carry out titrimetric assay of mefenamic acid capsules and tablets as per the British Pharmacopoeia(2008) specifications.

  4. EXPERIMENTAL Identity Test • 0.25g of mefenamic acid samples were weighed and extracted with ether. • The combined extracts were washed with water and evaporated to dryness. • The dried residue was dissolved in absolute ethanol and evaporated to dryness on a rotary evaporator.

  5. Preparation of sample for running of I.R. spectrum • Approximately 1 mg of the sample was weighed and triturated with 150 mg of finely ground and dried potassium bromide. The mixture was carefully ground, spread uniformly in a suitable die and a pressure of about 8 Torr/cm2 was applied. • This process was repeated for all the samples. • The disks were then subjected to an IR spectrophotometer for analysis. Ref: Pharmaceutical chemistry manual, 2013

  6. TITRIMETRIC ASSAY • Twenty (20) mefenamic acid tablets and capsules were weighed individually and then grounded. • The powder was then dissolved in warm absolute ethanol which was initially neutralized with phenol red solution. • The resulting solution was titrated with 0.1M sodium hydroxide VS with phenol red solution being the indicator.

  7. RESULTS and DISCUSSION • Identity test

  8. TITRIMETRIC ASSAY

  9. CONTENT OF MEFENAMIC ACID TABLETS AND CAPSULES Note: B.P. (2008) specifications for mefenamic acid content: Not less than 95% and not more than 105% of the label claim.

  10. CONCLUSION, LIMITATIONS AND RECOMMENDATIONS • All samples analyzed complied with BP 2008 specifications for identification and assay of mefenamic acid in mefenamic acid tablets and mefenamic acid capsules. • Due to limited time to collect the sample from different retail shops found within Nairobi, the sample size was a bit too small to conclude on the quality of different brands of mefenamic acid being sold in the market. • A more comprehensive study needs to be carried out with a larger sample size from different regions in the country for a better picture on the quality of mefenamic acid available in Kenya. • Post market surveillance should be an ongoing exercise to ensure continued adherence to quality.

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