Assay and Early Eluting impurities analysis of Gabapentin using a C18 HPLC column by USP 39 monograph

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for assay and early eluting impurities analysis of gabapentin. 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 theoretical plates met the criteria stated in the USP 39. The results obtained for resolution between gabapentin related compound A and gabapentin related compound B was 5.4 (USP criteria of NLT 2.3) and theoretical plates for gabapentin (2.3 mg/mL) was 3660 (USP criteria of minimum 1900).