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 5
Accuracy data of related substances.
Component
Recovery results (mean % recovery (%RSD))a
LOQ level; amount (% w/w)
50% of specification levelb; amount (% w/w)
100% of specification levelb; amount (% w/w)
150% of specification levelb; amount (% w/w)
Imp-A
116.67 (0.00)
106.67 (3.00)
104.00 (2.00)
104.15 (3.00)
Imp-B
116.67 (0.00)
114.86 (3.00)
111.94 (2.00)
113.36 (3.00)
Imp-C
112.50 (0.00)
102.67 (3.00)
100.22 (2.00)
100.30 (3.00)
aAverage % recovery and % RSD of results of three determinations.
b0.15% of all related substances.
