Chromatography Research International

Research Article

Development and Validation of Stability-Indicating GC-FID Method for the Quantitation of Memantine Hydrochloride and Its Nonchromophoric Impurities in Bulk and Pharmaceutical Dosages

Table 3

Linearity, limit of detection (LOD), and limit of quantitations (LOQ) data for memantine hydrochloride and related substances.
ComponentLinearity results (LOQ to 250% of specification levela)LOQ LOD results
Regression equationCCb (r)LOQ μg/mL, (% w.r.t.)cLOD μg/mL, (% w.r.t.)c
Imp-A = 1236.60 − 346.021.000002.941 (0.006)0.971 (0.002)
Imp-B = 817.18 − 5032.360.999515.421 (0.011)1.789 (0.004)
Imp-C = 992.21 − 602.220.999993.491 (0.007)1.152 (0.002)
Memantine = 921.02 − 2420.300.999915.985 (0.012)1.975 (0.004)
a0.15% of all related substances and 0.10% of memantine hydrochloride.
bCC: correlation coefficient.
cLOD LOQ values are in % with respect to test concentration of 50 mg/mL.