The Thermo Scientific Vanquish UHPLC system was used for the assay and organic Impurities of minocycline Periodontal System. The analysis was performed on a Thermo Scientific Accucore XL-C8 HPLC column using the method described in the USP43-NF38 . The results obtained for resolution and tailing factor met the criteria stated in the USP43-NF38. The result obtained for resolution between the peaks due to epiminocylcine and minocycline was 4.8 (USP criteria of minimum 2.0 ).
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).
