Development and Validation of a Stability Indicating LC Method for the Assay and Related Substances Determination of a Proteasome Inhibitor Bortezomib

Table 5

Accuracy study.

Added % (𝑛=3)	Assay		Related substances determination
	Added (in ppm)	% Recovery	% RSD	Added (in ppm)	Imp-A		Imp-B		Imp-C		Imp-D		Imp-E		Imp-F		Imp-G		Imp-H		Imp-I
					Recovery (%)	RSD (%)	Recovery (%)	RSD (%)	Recovery (%)	RSD (%)	Recovery (%)	RSD (%)	Recovery (%)	RSD (%)	Recovery (%)	RSD (%)	Recovery (%)	RSD (%)	Recovery (%)	RSD (%)	Recovery (%)	RSD (%)
50	500	99.8	0.4	0.75	105.5	1.5	104.8	2.9	104.7	3.1	105.2	2.0	96.5	2.5	102.2	2.2	103.3	1.3	99.7	0.5	99.5	2.5
100	1000	99.6	0.4	1.50	104.8	2.5	102.6	1.1	104.1	1.4	106.4	2.7	105.2	2.2	101.5	1.4	101.4	2.6	97.9	1.1	108.3	2.9
150	1500	99.9	0.3	2.25	106.7	1.2	102.5	1.1	107.4	2.1	94.2	2.3	101.1	0.6	97.3	0.7	101.8	2.3	103.1	0.8	99.8	1.6