PEMBUATAN KANDIDAT BAHAN BAKU PEMBANDING PRIMER ASAM MEFENAMAT DARI ASAM MEFENAMAT DERAJAT FARMASI
As an active pharmaceutical ingredients (API), Mefenamic acid (MA) should fulfill safety, efficacy and quality requirements. In the implementation of compendial methods safety and efficacy aspects are assured by means of quality testing in which a reference standard is needed. The aim of this res...
Saved in:
| Main Author: | |
|---|---|
| Format: | Final Project |
| Language: | Indonesia |
| Online Access: | https://digilib.itb.ac.id/gdl/view/44318 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| Institution: | Institut Teknologi Bandung |
| Language: | Indonesia |
| Summary: | As an active pharmaceutical ingredients (API), Mefenamic acid (MA) should fulfill safety, efficacy
and quality requirements. In the implementation of compendial methods safety and efficacy
aspects are assured by means of quality testing in which a reference standard is needed. The aim
of this research was to obtain a primary reference standard candidate of MA from a pharmaceutical
grade MA. Pharmaceutical grade MA was purified by recrystallization method applying suitable
solvents followed by various physicochemical characterizations. Recrystallization in ethanol with
carbon active addition resulted in pure product which was monitored by TLC and HPLC testing. Ethyl
acetate : Chloroform (1:3) and Acetonitrile : 50 mM potassium dihydrogen phosphate buffer (3:2)
were used as mobile phases of TLC and HPLC, respectively. Further characterization with FTIR,
1
H
and
13
C NMR and High resolution MS spectrophotometry measurements confirmed that the
product was pure and showed the structure of mefenamic acid with relative molecular mass of
241.118 g/mol. Loss on drying and residue on ignition testing revealed that the purified MA has the
assigned value of 99.94%. Based on overall results, it was concluded that the primary reference
standard candidate of MA was successfully obtained.
|
|---|