Validation of Quantitative HPLC Method for Bacosides in KeenMind

Table 7

Summary of validation results.

Test	Limits	Conclusions/results
Specificity	No interfering peaks with that of the target.	Complies, however, bacoside peaks are coeluting
Linearity; (calibration coefficient)	The Y-intercept should not be more than ±2%.	0.38%
	Linearity
Instrument precision	The % RSD of the retention time is ≤1.0%	0.24% RSD
	The % RSD of the peak area is ≤10.0%	0.073% RSD
Detection limit	≥ 3	0.00445 mg/mL
Quantitation limit	≥ 10	0.0089 mg/mL
Method precision	The mean result at method working strength is within the specification	Pass (1.02 %w/w)
	The % RSD is ≤10.0%	3.0% RSD
Intermediate precision	The mean result at method working strength is within the specification	Pass (1.02 %w/w)
	The % RSD is ≤10.0%	2.5% RSD
Extraction efficiency	>95% recovery from first extract	97.7% of total recovered
Accuracy/recovery	At concentrations ranging from 80 to 120% of nominal stated content, the recovery Bacopaside II is 90.0% to 110.0%	Sample	%
		80	100.51
		100	102.76
		120	104.97
Range	Precision, accuracy, and linearity must meet their criteria from LOQ% to 150% of the label claim	0.00445–0.89 mg/mL