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
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.
PREPARATION OF SAMPLE FOR
RUNNING OF I.R. SPECTRUM
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
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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
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
FREQUENCIES( CM-1)
FUNCTIONAL GROUP
1650
C=C
1565-1575
N-H
1100
C-O
750
phenyl group
TITRIMETRIC ASSAY
PRODUCT
MEAN TITRE VALUES (mL)
0010
19.6
0020
20.2
0030
19.7
0040
19.6
0050
21.5
0060
20.4
0070
20.6
0080
19.6
CONTENT OF MEFENAMIC ACID
TABLETS AND CAPSULES
0010
% CONTENT OF LABEL CLAIM
OBTAINED
95.0%
0020
98.0 %
0030
95.0 %
0040
95.0%
0050
104.0 %
0060
98.8%
0070
99.8%
0080
95.0%
SAMPLE
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
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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.