PEMBUATAN KANDIDAT BAHAN BAKU PEMBANDING PRIMER ASAM MEFENAMAT DARI ASAM MEFENAMAT DERAJAT FARMASI

• Main Author: Putri Syamsuri, Dianisa
• Format: Final Project
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/44318
• Institution: Institut Teknologi Bandung

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.