Validation Thin Layer Chromatography for the Determination of Acetaminophen in Tablets and Comparison with a Pharmacopeial Method

Table 3

Method-validation data for the quantitative determination of acetaminophen by NP-TLC with densitometry^a.

Method characteristic	Results
Specificity	Specific
Range [μg · spot^−1]	0.40÷1.75
Linearity [μg · spot^−1]	A = 2444.4(±68.3) + 7249.8(±63.7) · x
	𝑛=8; 𝑟=0.9998; 𝑠=83.0; 𝐹=12952; 𝑃<0.0001
Detection limit (DL) [μg · spot^−1]	0.09
Quantitation limit (QL) [μg · spot^−1]	0.27
	For tablets
	Product 1	Product 2	Product 3
Accuracy
For 50% acetaminophen added (𝑛=6)	𝑅=100.72%; CV = 1.13%	𝑅=99.69%; CV = 0.91%	𝑅=101.34%; CV = 1.29%
For 100% acetaminophen added (𝑛=6)	𝑅=100.58%; CV = 1.21%	𝑅=99.63%; CV = 0.92%	𝑅=102.34%; CV = 1.33%
For 150% acetaminophen added (𝑛=6)	𝑅=101.23%; CV = 0.86%	𝑅=99.27%; CV = 1.12%	𝑅=100.87%; CV = 1.08%
Precision (CV, [%])
Repeatability
For 0.50 𝜇g · spot^−1 (𝑛=3)	0.57	0.85	0.99
For 1.00 𝜇g · spot^−1 (𝑛=3)	0.66	0.76	0.78
For 1.50 𝜇g · spot^−1 (𝑛=3)	1.00	0.73	1.11
Intermediate
For 0.50 𝜇g · spot^−1 (𝑛=3)	0.85	1.41	1.11
For 1.00 𝜇g · spot^−1 (𝑛=3)	1.20	1.57	0.99
For 1.50 𝜇g · spot^−1 (𝑛=3)	1.13	1.36	1.56
Robustness (CV, [%])	Robust	Robust	Robust

^a𝐴: peak area [AU], x: amount [𝜇g · spot⁻¹] of drug analyzed, r: correlation coefficient, R: recovery [%], CV: coefficient of variation [%].