Pharmacopeial assay and related substances analysis of minocycline hydrochloride using a C8 HPLC column

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the assay and related substances analysis of minocycline hydrochloride. The analysis was performed on a Thermo Scientific Hypersil GOLD C8 HPLC column using the method described in the EP 8.0. The results obtained for resolution and theoretical plates met the criteria stated in the EP. The results obtained for resolution between the peaks due to impurity A and minocycline was 4.3 (EP criteria of minimum 2.0) and theoretical plates for minocycline (0.125 mg/mL) was 6376 (EP criteria of minimum 3000).

Pharmacopeial assay and organic impurities analysis of Minocycline hydrochloride using a C18 HPLC column

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for assay and organic impurities analysis of minocycline hydrochloride. The analysis was performed on a Thermo Scientific Acclaim 120 C18 HPLC column using the method described in the USP 39 monograph. The results obtained for resolution and tailing factor met the criteria stated in the USP 39. The results obtained for resolution between epiminocycline and minocycline was 7.5 (USP criteria of NLT 4.6) and tailing factor of minocycline (0.5 mg/mL) was 0.94 (USP criteria of 0.9 to 2.0).