A RP-HPLC Method for the Analysis of Neostigmine Methylsulfate and Process-Related Impurities, Forced Degradation Studies, in the Injection Formulation

Table 5

System suitability parameters for neostigmine methylsulfate impurities in API.

Component names	RT (min)	RRT	Area	Theoretical plates	Tailing factor	Resolution	Purity angle	Purity threshold
Impurity A	4.841	0.4689	39322	21703	1.23	6.29	1.791	2.365
Impurity B	7.882	0.7602	3170	33200	1.20	18.99	16.099	19.496
Impurity C	29.606	2.8623	61058	91925	1.05	7.78	1.150	2.096