High-throughput prediction of tablet weight and trimethoprim content of compound sulfamethoxazole tablets for controlling the uniformity of dosage units by NIR

• A high-throughput and rapid NIR-PLS method was developed and evaluated.
• The tablet weight of compound sulfamethoxazole tablets was determined.
• The trimethoprim content of compound sulfamethoxazole tablets was determined.
• The work expands NIR applications in controlling the uniformity of dosage units.
• The strategy can be used in the on-line analysis of pharmaceutical tablets.

This paper establishes a novel method to simultaneously predict the tablet weight (TW) and trimethoprim (TMP) content of compound sulfamethoxazole tablets (SMZCO) by near infrared (NIR) spectroscopy with partial least squares (PLS) regression for controlling the uniformity of dosage units (UODU). The NIR spectra for 257 samples were measured using the optimized parameter values and pretreated using the optimized chemometric techniques. After the outliers were ignored, two PLS models for predicting TW and TMP content were respectively established by using the selected spectral sub-ranges and the reference values. The TW model reaches the correlation coefficient of calibration (Rc) 0.9543 and the TMP content model has the Rc 0.9205. The experimental results indicate that this strategy expands the NIR application in controlling UODU, especially in the high-throughput and rapid analysis of TWs and contents of the compound pharmaceutical tablets, and may be an important complement to the common NIR on-line analytical method for pharmaceutical tablets.

Figure optionsDownload as PowerPoint slide