[A near-infrared diffuse reflectance analysis method for the noninvasive quantitative analysis of ambroxol hydrochloride tablets].
OBJECTIVE
To develop a near-infrared diffuse reflectance analysis (NIRDRA) method for rapid noninvasive quantitative determination of ambroxol hydrochloride in half-finished product particles and non-blister-packed, blistered tablets.


METHODS
All spectra were measured with a Fourier transform spectrometer equipped with a PbS and a InGaAs detector, an external integrating sphere, a rotating sample cup, and a fibre-optic probe for reflectance measurements. All samples were scanned from 12,000 cm-1 to 4,000 cm-1, and each sample spectrum was obtained as an automatic mean of 64 scans. No spectrum pre-processing method was used, and spectral regions, 4,602-4,247, 12,000-7,498 and 6,102-5,446, 12,000-5,446 cm-1 were selected to develope mathematical models by partial least square method for half-finished product particles and non-blister-packed, blistered tablets samples, respectively.


RESULTS
The optimal rank and mean square error determined for half-finished product particles and non-blister-packed, blistered tablets samples by cross validation method all was 6 and 0.306, 0.972 and 1.492, respectively, the average recovery was 100%, 100% and 102% respectively; and the RSD was 1.17%, 1.70% and 1.78% respectively.


CONCLUSIONS
Results showed that the NIRDRA method was rapid, simple, noninvasive and sensitive, and it can be applied to assay the content of ambroxol hydrochloride in half-finished product particles non-blister-packed and blistered tablets.
Sun
Mei-ling
ML
Center for Instrumental Analysis, China Pharmaceutical University, Nanjing 210009, China.
Xiang
Bing-ren
BR
An
Deng-kui
DK
D000551:Ambroxol / Q000008:administration & dosage / Q000032:analysis*; D005100:Expectorants / Q000008:administration & dosage / Q000032:analysis*; D011786:Quality Control; D019265:Spectroscopy, Near-Infrared / Q000379:methods*; D013607:Tablets
D005100:Expectorants; D013607:Tablets; D000551:Ambroxol