title: Development and validation of a stability-indicating RP-HPL C-CAD method for gabapentin and its related impurities in presence of degradation products.
abstract: The objective of the current study was to develop and validate a sensitive and specific LC-MS compatible stability indicating reversed phase liquid chromatographic method for the quantitative determination of Gabapentin and its related substances using Corona charged aerosol detection (CAD). The chromatographic conditions were optimized using a Kinetix Biphenyl column with gradient elution using a mobile phase composed of pH 4.2 ammonium acetate, acetonitrile, and methanol. Forced degradation was observed in basic and peroxide conditions and the major degradants were identified by LC-MS/MS analysis. The developed RP-HPLC CAD method was validated according to ICH guidelines. The LOD and LOQ values for Gabapentin and all its related impurities ranged from 0.075μg/mL to 0.18μg/mL and 0.25μg/mL to 0.60μg/mL, respectively. The recovery for all impurities ranged from 91.0 to 105.6%w/w. Solutions were stable for 7days at room temperature. The validated method produced acceptable precision, linearity, accuracy, robustness and ruggedness.
authors.affiliation: Department of Chemistry, Jawaharlal Nehru Technological University, Kakinada 533003, India. Electronic address: pkumar1599@gmail.com.
authors.forename: Pramod Kumar
authors.initials: PK
authors.lastname: Ragham
authors.affiliation: Department of Chemistry, Jawaharlal Nehru Technological University, Anantapur 515002, India.
authors.forename: Kothapalli B
authors.initials: KB
authors.lastname: Chandrasekhar
mesh_terms: D000588:Amines / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D056148:Chromatography, Reverse-Phase / Q000379:methods*; D003509:Cyclohexanecarboxylic Acids / Q000032:analysis*; D000077206:Gabapentin; D021241:Spectrometry, Mass, Electrospray Ionization; D005680:gamma-Aminobutyric Acid / Q000032:analysis*
chemical_list: D000588:Amines; D003509:Cyclohexanecarboxylic Acids; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin
keywords: Corona charged aerosol detector (CAD); Forced degradation; Gabapentin; Related substances; Stability-indicating assay