Research Article

Comprehensive Study of a Handheld Raman Spectrometer for the Analysis of Counterfeits of Solid-Dosage Form Medicines

Table 4

Results of the four robustness tests. The conditions of the test, like the sampling, have been added together with the number of spectra measured. The results consist in the value range and the pass/fail answers.

Robustness testProductConditionsNumber of
spectra
pVal resultsIdentification against the corresponding method

R1: degradation
with the laser
Product 20No change in sample position20[0.5745–0.6669]Pass
Product 31No change in sample position20[0.5616–0.7335]Pass

R2: influence of
the sample position
Product 20Sample position changed10[0.5523–0.6746]Pass
Product 31Sample position changed10[0.3316–0.6481]Pass

R3: influence of
the sampling
Product 20Glass vial3[0.5386–0.5950]Pass
Transparent blister3[0.5891–0.6534]Pass
Direct3[0.5344–0.5746]Pass
Product 32Glass vial3[0.1131–0.2471]Pass
Transparent blister3[0.0814–0.3385]Pass
Direct3[0.1628–0.4482]Pass
Product 27White blister3[0.0175–0.0259]Fail
White blister3[0.0272–0.1164]Fail
White blister3[0.0017–0.0731]Fail

R4: influence of
the operator
Product 20Operator A3[0.6815–0.6871]Pass
Operator B3[0.6143–0.6526]Pass
Product 31Operator A3[0.6159–0.6779]Pass
Operator B3[0.6599–0.7381]Pass