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 4

Validation data results of related substances and assay of memantine hydrochloride.

Compound	Related substances results			Assay results
	Imp-A	Imp-B	Imp-C	Memantine
Precision (mean results ± %RSD)
Method precision (𝑛=6)	0.155±1.29	0.167±1.20	0.153±1.31	99.9±0.44
Intermediate precision (𝑛=6)	0.165±1.21	0.165±1.82	0.168±1.19	100.4±0.73
Overall results (𝑛=12)	0.160±3.13	0.166±1.81	0.161±4.97	100.1±0.62