EP 8.0 monograph - impurity analysis of mefenamic acid using a C18 HPLC column

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the analysis of mefenamic acid and its impurities. The separation was performed on a Thermo Scientific Hypersil GOLD column using the method described in the EP 8.0 monograph. Resolution between impurity C and impurity D in reference solution (b) was 4.5 (exceeding EP criteria of minimum 3.0). Retention time of mefenamic Acid was 8.16 minutes (meeting EP criteria of about 8 minutes). Relative retention time criteria was also exceeded.

USP 38 monograph - assay analysis of mefenamic acid using a C18 HPLC column

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the assay analysis of mefenamic acid. The analysis was performed on a Thermo Scientific Acclaim 120 C18 HPLC column using the method described in the USP 38 monograph. The results for column efficiency for the standard solution was 15158 (exceeding the USP criteria of not less than 8200). The tailing factor results for mefenamic acid in standard solution was 0.83 (USP criteria not more than 1.6). The % RSD for replicate injection of standard solution was 0.19% (exceeding the USP criteria not more than 1.0%)

An accurate determination of mefenamic acid and impurities from formulation using reversed-phase HPLC-UV

Instrument Type: HPLC

The Thermo Scientific Dionex Ultimate 3000 system is applied for the analysis of a mefenamic acid in formulation. The separation is performed on a Thermo Scientific Syncronis C18 HPLC column in less than 30 minutes, with UV detection at 254 nm.