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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).

The late 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 the late 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 theoretical plates and %RSD met the criteria stated in the USP 39. The results obtained for theoretical plates of gabapentin related compound D was 22,140 (USP criteria of NLT 13,600) and %RSD for gabapentin related compound D was 1.4% (USP criteria of NMT 7.0%).

Rapid determination of Pregabalin in human plasma by SPE-LC-MS/MS using Thermo Scientific SOLA SCX mixed mode SPE cartridges and a Thermo Scientific Accucore PFP HPLC column

Instrument Type: LCMSMS

A simple, rapid and sensitive procedure for the determination of pregabalin in human plasma by LC-MS/MS was developed and evaluated. The drug was isolated from a plasma matrix using Thermo Scientific SOLA SCX solid phase extraction material, and the components of the resultant extracts were separated on a Thermo Scientific Accucore PFP HPLC column. Detection was performed on a triple quadrupole mass spectrometer. For Research Use Only. Not for use in diagnostic procedures.