High-throughput NIR-chemometric method for direct quantification of loratadine in powder blends for tableting and tablets

Abstract

Objectives. The aim of this study was to develop and validate a NIR-chemometric method for direct quantification of loratadine in powder blends for tableting and tablets, without any sample preparation. Material and methods. Calibration samples were prepared according to an experimental design with 1 variable and 5 level, containing from 8 to 12 mg loratadine/tablet. Outcomes. For the powder blends, the model generated with the use of spectral range 9,000-4,000 cm-1 and FD+SNV pre-treatment method had the best results, considering the number of PLS factors 9, R2 = 0.984 and RMSECV = 0.267%. For the tablets, the model using the spectral range 11,100-7,128 cm-1 and mMN pre-treatment method had the best results, considering the number of PLS factors 10, R2 = 0.985 and RMSECV = 0.170 mg. Using these calibration models, the method was fully validated according to the ICH guidance. For both powder blends and tablets, the best accuracy was obtained at the concentration level of 10 mg/tablet and the relative bias had values between 0.05% and 1.98% respectively -0.360% and 0.618%. Conclusions. The NIR-chemometric method has good reproducibility and satisfactory accuracy and linearity profiles, indicating that this method could be used for direct determination of loratadine in powder blends for tableting and tablets, without any sample preparation.

Keywords

• loratadine assay
• near infrared spectroscopy
• chemometry
• process analytical technology