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  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

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.

EXPERIMENTAL  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. Identity Test

P REPARATION 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/cm 2 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

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.

RESULTS AND DISCUSSION  Identity test FUNCTIONAL GROUP C=C N-H C-O phenyl group FREQUENCIES( CM -1 )

TITRIMETRIC ASSAY PRODUCTMEAN TITRE VALUES (mL)

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

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.