Near-Infrared Assay and Content Uniformity of Tablets - Pharmaceutical Technology

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Near-Infrared Assay and Content Uniformity of Tablets
Near-infrared (NIR) assay and content uniformity of tablets provide fast, accurate means of monitoring tablet production that are in step with FDA's process analytical technology initiative.The authors discuss the process for testing a newly released NIR tablet analyzer to determine instrument precision and accuracy using chlorpheniramine maleate tablets.The data show promising results that could relieve laboratory workload of high-performance liquid chromatography analysis and bring analysis closer to..


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Table I: Prediction equation statistics.
Partial least squares (PLS) regression was used to develop the prediction model. PLS uses principal component analysis and is a variation of principal component regression (PCR). The correct number of principal components or factors was determined by the Vision software supplied with the instrument by determining where the predicted residual error sum of squares (PRESS) reaches a minimum (5).


Table II: Repeatability results for 0.1 mg and 0.5 mg tablets of chlorpheniramine maleate (CPM).
Figures 5 and 6 are plots of the PLS factor loadings and weights around the 1138-nm absorption band for CPM. The loadings and weights appear spectra-like and are not noisy, indicating good modeling attributes for the factors chosen. Figure 7 is a plot of the PRESS leading to a model with eight factors. The model chosen used only six of these factors, trading decreased error for robustness (6). The PRESS for six factors was 0.0095. The resulting model had a multiple correlation coefficient (R 2 ) value of 0.9998 and a standard error of calibration (SEC) of 0.0119. The one-left-out cross-validation demonstrates good predictability with a standard error of cross-validation of 0.0148.







Table III: Content uniformity test results for ten 0.1-mg chlorpheniramine maleate tablets.
Table I contains the model statistics for the CPM prediction equation. Table II is the repeatability results for five tablets measured 10 times each of nominal 0.1 mg CPM and 10 tablets of 0.5 mg CPM. The same tablet placed in the same tray position was scanned 10 times. Data for tablet tray position (number 1) are shown, and only the combined statistical results are shown for the other four tablets from each dosage level. The average precision for the nominal 0.1-mg level was 0.0039. The precision for the nominal 0.5-mg level was 0.0055. The bias was 0.0018 for the lower-level CPM and 0.0057 for the higher level. Table III contains the results from scanning the ten 0.1 mg CPM tablets for content uniformity. Table IV contains the results from scanning the ten 0.5-mg CPM tablets for content uniformity. The Vision software has a convenient routine analysis method for calculating content uniformity automatically. Figures 8 and 9 are X control charts for the 0.1-mg and 0.5-mg CPM content uniformity tests. These charts are for SPC, plotting target label claim and 15% control limits. The HPLC results showed that some of the nominal 0.5-mg CPM tablets were as high as 0.53 mg CPM.


Table IV: Content uniformity test results for ten 0.5-mg chlorpheniramine maleate (CPM) tablets.


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