Table II.

Validation Parameters for the API Quantitation with the Models for Tablets and Granulated Samples

		Model
		Granulate	Tablets
	Compound	Correlation coefficient
Selectivity	Enantyum granulated	>0.99	–
	Coated tablets	–	1
	Uncoated tables	–	0.99
	Maize starch	0.75	0.76
	Microcrystalline cellulose	0.90	0.86
	Carboxymethyl starch	0.79	0.70
	Dexketoprofen	0.31	0.30
	Glycerol palmitoestearate	0.24	0.33
	Parameter	Results
Linearity	n	20	8
	Concentration range (mg/g)	75.6–120.6	74.1 – 112.5
	Intercept	−0.02 ± 4.54	3.9 ± 10.6
	Slope	1.00 ± 0.05	0.96 ± 0.12
	R	0.995	0.993
Accuracy	n	10	10
	Avg. difference (mg/g)	−0.33	0.17
	SD	1.87	1.00
	t exp	1.11	0.54
	t crit	2.23	2.26
Repeatability	Replicates	6	6
	Mean NIR (mg/g)	94.64	91.22
	CV (%)	0.39	0.21
Intermediate	Days (3)	F exp 13.7	F exp 0.66
		F tab 19.00	F tab 19.00
Precision	Analysts (2)	F exp 0.07	F exp 0.09
		F tab 18.51	F tab 18.51
	CV (%)	0.72	1.17
Robustness	n	20	14
	t exp	0.56	0.41
	t crit	2.09	2.16