Peroza Meza, Carlos A.

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    Development and validation of a method for testing content uniformity on pharmaceutical potent oral dosage forms by near-infrared spectroscopy
    (2005) Peroza Meza, Carlos A.; Romañach, Rodolfo J.; College of Arts and Sciencies - Sciences; Roman, Félix; Acuña, Edgar; Department of Chemistry; Resto, Pedro
    A transmission Near Infrared (NIR) spectroscopic method was developed for the non-destructive determination of drug content in tablets with less than 1% (m/m) drug content along with a sample size study to determine the real sample volume of the material being analyzed. Tablets used had nominal drug concentrations of about 0.5 %, 0.7%, and 1.0 % (m/m) and ranging in drug content from 0.71 to 2.51 mg per tablet. Transmission NIR spectra were obtained for 110 tablets that constituted the training set for the calibration model developed with partial least squares (PLS) regression. The reference method for the calibration model was a validated UV spectrophotometric method. Several data preprocessing methods were used to reduce the effect of scattering on the NIR spectra and base the calibration model on spectral changes related to the drug concentration changes. The final calibration model included the spectral range from 11,216 – 8,662 cm⁻¹, along with the Standard Normal Variate (SNV) and first derivative as spectral pretreatments. This model was used to predict an independent set of 48 tablets with a root mean standard error of prediction (RMSEP) of 0.14 mg, and a bias of – 0.05 mg per tablet. The sample volume study showed that nearly the 51 % of the total volume of a tablet is sampled with a 7 mm holder. The study also showed that transmission NIR spectroscopy can be used as an alternative tool for non-destructive testing of low drug content tablets for the analysis of large numbers of tablets during process development and as a tool to detect drug agglomeration and evaluate process improvement efforts.