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

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

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)

1650

1565-1575

1100

750

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

SAMPLE % CONTENT OF LABEL CLAIM

OBTAINED

0010 95.0%

0020 98.0 %

0030 95.0 %

0040 95.0%

0050 104.0 %

0060 98.8%

0070 99.8%

0080 95.0%

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.